cover letter for application fda

Department of Health and Human Services
National Institutes of Health

Regulatory Toolbox

Initial ind application.

The initial IND submission to the FDA will provide the reviewers with the information necessary to conduct a thorough evaluation of the safety of the investigation, and its scientific merit. The submission is divided into several sections. The summaries listed in this page will provide detailed instructions to prepare a complete IND submission.

Form FDA 1571

Current version of Form FDA 1571

Form FDA 1571 Instructions

The purpose of the Form FDA 1571 is to:

obtain agreement from the sponsor (or sponsor-investigator) to conduct research according to all appropriate FDA regulations; and
serve as a cover sheet for all submissions to the FDA on behalf of a particular IND.

Form FDA 1571 should be completed for every submission sent to the FDA on behalf of a particular IND and should include the below:

Contact information and mailing address of the Sponsor (or Sponsor Investigator)
IND number, if it has been issued
Serial number (see below)
The name(s) of the drug/biologic and the indication being studied
The contents of the submission
Name and title of the individuals responsible for monitoring the study and reviewing safety data.

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Form FDA 1572

Frequently Asked Questions – Statement of Investigator (Form FDA 1572)

Current version of Form FDA 1572

Form FDA 1572 Instructions

The intent of the 1572 form is two-fold. It is a signed agreement from the Investigator (i.e., Principal Investigator) that he/she will conduct the research in compliance with FDA regulations. Additionally, it collects all the clinical site and investigator information needed by the sponsor to assure the FDA that all investigators have the experience and background needed to conduct the trial. The site investigator is responsible for updating his/her 1572 form and providing it to the sponsor in a timely manner so the information can be sent to the FDA. (Although it is not a requirement for the updated 1572 to be submitted to the FDA, it is the responsibility of the sponsor to provide updated information to the FDA; therefore the 1572 is often submitted to the FDA rather than providing information in another format.)

The Form FDA 1572 is necessary to include in an initial IND submission and must be filled out when adding a new principal investigator at each site.

Please note that a 1572 must be submitted to the FDA within 30 days of the investigator being added and when changing any site information, i.e., IRB, laboratory, or clinical site.

Additional information to be provided:

A current CV or statement of qualifications of the principal investigator listed on the 1572. It does not need to be signed.
Name and address of the location where the clinical investigation will be conducted, the clinical laboratories that will be used, and the IRB reviewing the study.
To note, it is not a requirement to fill out a new 1572 when there is a Sub-Investigator change as long as this information is sent in a timely manner to the sponsor. However, the 1572 is often used for updates to have all information in an organized place.

Form FDA 3674 - Certification of Compliance

Current version of Form FDA 3674

Form FDA 3674 Instructions

The Form FDA 3674 is a document that must accompany the initial submission, and when submitting a new protocol to IND. It is a signed statement from the sponsor that they will comply with clinicaltrials.gov requirements concerning their investigation.

It is a requirement for NIH trials to be registered on clinicaltrials.gov. OPS is responsible for registering studies on clinicaltrials.gov and the study team is responsible for updating this information when primary endpoints are met. Please see FDAAA 801 Requirements at clinicaltrials.gov for more information.

Cover Letter

The cover letter is the first piece of information that the FDA sees upon receipt of an Initial IND submission. It expresses the intent of the investigator to request FDA review of the enclosed information, and briefly describes the proposed research. It is the responsibility of the sponsor to compose the cover letter.

Items to include in the cover letter:

The cover letter should be on departmental letterhead
Title the cover letter: "Initial Investigational New Drug Application"
Brief explanation of the investigation (i.e., use the study title)
Disease or condition being studied
Name, formulation, and proposed dose of drug product.
Contact information (phone, email, address) of the Sponsor and (recommended) a designated individual authorized to interact with the FDA on the Sponsors behalf.
Ensure the date of the cover letter matches the date on the signed copy of Form FDA 1571.
If the sponsor and FDA have already had a Pre-IND meeting, then this should be noted in the letter, and reference the PIND number and date of meeting.

The cover letter can be short, ~ 1-2 pages, and should be addressed to either the appropriate CDER/CBER Division Director with a copy sent to the Division's Chief of Project Management staff or to the appropriate office contact within CDER/CBER. This should also be the mailing address for the entire submission:

For a Drug: Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Rd. Beltsville, Md. 20705-1266

For a Therapeutic Biological Product: Food and Drug Administration Center for Drug Evaluation and Research Therapeutic Biological Products Document Room 5901-B Ammendale Road Beltsville, MD 20705-1266

For a Biological Product: U.S. Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Letter of Support / Authorization

If a sponsor is proposing to evaluate a drug that is the subject of an existing IND, they can request a letter of cross-reference authorization from the sponsor of that existing IND. This permits the sponsor to refer the FDA to the information contained in the referenced IND, and maintain the confidentiality of their proprietary information. The FDA can use the original IND material, along with their own internal reviews of that material to assist in their review process. Additionally, an IND for a drug that has been approved by the FDA for commercial use, may require more information than what is provided in the package insert. Again, the sponsor may request a letter of cross-reference authorization from the commercial sponsor. Commercial sponsors should provide the IND, NDA, or BLA file name, reference number, volume, and page numbers where the FDA can find the information relevant to the referencing IND application. In general, INDs that are withdrawn or inactive cannot be cross-referenced.

Sections of the Initial IND

The initial IND submission to the FDA is broken down into several distinct sections. Each section addresses a topic necessary for FDA review. The links below will provide a detailed description of each section and provide guidance on what information should be included in the IND submission.

The Investigator-Initiated Investigational New Drug (IND) Applications website has all the information to get from start to finish with an application to the FDA.

Introduction

The introduction should briefly describe the research plan submitted in this IND, including a discussion of the disease state to be assessed. The intent of this section is to place the use of the drugs with this indication into perspective for the FDA. This section should include the product’s active ingredients, pharmacological class, structural formula and dosage form, and route of administration. The study objectives and proposed timeline should be stated. Additionally, include the status of the drug in other countries, i.e., if the product has been withdrawn from investigator or marketing for any reason related to safety or effectiveness.

This section will include a brief summary of previous human experience with the drug, with reference to the relevant literature or other INDs, if pertinent. Also, investigational or marketing experience in other countries may be relevant to the safety of the proposed clinical investigation. This topic will be written up in further detail in the “Previous Human Experience” section.

General Investigational Plan

As the studies contained in this IND progress from phase 1 to phases 2 and 3, the contents of this section will change. For the purpose of the initial submission, information that will be relevant for the first year of investigation should be included. Changes to the plan and additional protocols can be included in future annual reports and amendments. This should include:

The rationale for the drug and/or research study and enough background information on the topic for the FDA to understand the scientific justification for the investigation.
Identification of the indication to be studied in this investigation, including sub-sets of a more general study population if needed.
A high-level description of data to be collected and its use in evaluation of the efficacy of the intervention being studied.
A high-level description of the plan for the first 12 months of clinical investigation. The FDA understands that study plans may change over time.
The planned number of subjects to be enrolled in the first year of IND activity.
Any risks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug(s) or related drugs. Any study procedures that carry risks of more than minimal severity should be included.

Investigator Brochure

For single site INDs where an NIH Institute or Center (IC) is the Sponsor and an employee of the IC is the investigator, it is generally acceptable to ask for a waiver for the Investigator Brochure, much like a sponsor-investigator study. The following statement may be incorporated into the application:

"As this is a single site study with the investigator initiating the study and being employed by the sponsoring entity, we believe that an investigator’s brochure is not required per 21 CFR 312.55(a)."

If an approved drug is being investigated, then it is appropriate to refer to the labeling and provide a URL link to the most current product label. Links that may be helpful are:

Drugs@FDA: FDA Approved Drug Products

Letters of Authorization may also be referenced in this section.

If there will be a multi-center (external site) clinical investigation, an Investigator's Brochure should be developed for dissemination to each of the involved study sites and should address the following information:

A brief description of the active drug substance and the drug product formulation, including the structural formula of the active drug substance, if known.
A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
A summary of the pharmacokinetics and biological distribution of the drug in animals and, if known, in humans.
A summary of information relating to the safety and effectiveness of the drug in humans obtained from prior clinical studies. (Reprints of published articles describing such studies may be appended to the Brochure if they are anticipated to be useful.)
A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug.

Proposed Clinical Research

This section should contain the full study protocol document and informed consent document for each planned study.

Informed consent documents should be written in such a way that they can be understood by the general public. Language should be targeted at an elementary grade reading level. It is advisable to keep the document concise for the benefit of the reader. A statement should be included here that informed consent will be obtained by all study participants in accordance with 21 CFR Part 50, Protection of Human Subjects. If the investigation involves an exception from informed consent requirements, this should be stated in this section and the reasoning should be explained.

Chemistry, Manufacturing, and Control Information

If the investigational drug has been marketed, this section may be covered by referring to the product labeling. Refer back to the URL identified in the Investigator's Brochure section, if appropriate. Alternatively, it might be appropriate to refer to a Letter of Authorization if using a drug provided by a commercial company.

Drug Substance

This section should include:

Description of drug; included should be the physical, chemical, or biological characteristics and evidence supporting structure and identity of the active pharmaceutical ingredient(s)
Name and address of manufacturer of drug product
Description of the general method of preparation of the drug substance, including a list of the reagents, solvents, and catalysts used. A detailed flow diagram is suggested as the most effective presentation. More information may be needed to assess the safety of biotechnology-derived drugs or drugs extracted from human or animal or plant sources
The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug substance, with a brief description of the test methods used (i.e., Nuclear Magnetic Resonance, Infrared, UV spectra to prove the identity, and High-Performance Liquid chromatograms to support the purity level and impurities, etc.). Submission of certificates of analysis is also suggested.
Information to support stability of the drug substance during storage in the intended container closure and during the toxicological and clinical studies

Drug Product

A list of all components used in the manufacture of the investigational drug product, including both those components intended to appear in the drug product and those which may not appear but which are used in the manufacturing process
Where possible, the quantitative composition of the investigational drug product, including any reasonable variations that may be expected during the investigational stage
Brief general description of the manufacturing process (in the form of a flow diagram is suggested) and packaging procedure, as well as other relevant tests, as appropriate for the product. Final specifications for the drug product intended to be used in toxicological and clinical studies should be included. For injectable products, sterility and pyrogenicity tests, endotoxin levels and particulate matter should be included. Submitting a copy of the certificate of analysis of the clinical batch is also suggested. There should be information sufficient to assure the product's stability during the planned clinical studies.
The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug product
Information to support stability of the drug product during the planned clinical studies

Placebo Product

Include a brief general description of the composition, manufacture, and control of any placebo used in the controlled clinical trial.

Include copies of the label constructed for the study drug and any associated package.

Labels must contain the phrase: "Caution: New Drug - Limited by Federal law to investigational use".

Environmental Assessment

"We request a claim for categorical exclusion for this proposed clinical trial as provided for in 21 CFR Part 312.31(e) in that the drug shipped under this notice is intended to be used in clinical trials in which the amount of waste expected to enter the environment may reasonably be expected to be non-toxic."

Pharmacology and Toxicology Information

As was true for the Chemistry, Manufacturing and Controls section, an authorization letter may be used or a reference to the drug label to satisfy this section. This section is expected to include information about pharmacological and toxicological (laboratory animals or in vitro) studies on the basis that it is reasonably safe to conduct the proposed clinical investigation. The type, duration, and scope of these studies required in the application will depend on the duration and nature of the proposed clinical investigations.

Compliance with Good Laboratory Practice (GLP) is generally expected for pivotal in vitro and in vivo studies submitted in support of an IND application. For each non-clinical laboratory study subject to the GLP regulations, investigators are expected to state in the study report that the study was conducted in compliance with the GLP regulations. If the study was not conducted in compliance with the GLP regulations, there should be a brief statement of the reason for noncompliance.

The IND sponsor should also provide a statement describing where the non-clinical investigations were conducted and the location of all records available for inspection.

Pharmacology and Drug Distribution

This section should include a description of the pharmacologic effects and mechanism of actions of the drug in animals, and information on the absorption, distribution, metabolism, and excretions of the drug.

Note: The regulations do not further describe the presentation of these data, in contrast to the more detailed description of how to submit toxicological data. A summary report, without individual animal records or individual study results, usually suffices. In most circumstances, five pages or less should suffice for this summary. If this information is not known, it should simply be so stated.

Pharmacology Summary and Conclusions

A high-level summary and general conclusions to be drawn from the pharmacology data should be included in this section.

Toxicology: Integrated Summary

This section should include an integrated summary of the toxicological effects of the drug in pre-clinical studies. Expected content elements for describing specific toxicology studies for this section typically include:

Study title
Study drug formulation and dosing
Brief description of the design of the trials
Systematic presentation of the findings from the animal toxicology and toxicokenetic studies. The format of this part of the summary may be approached from a "systems review" perspective: i.e. CNS, cardiovascular, gastrointestinal, renal, hepatic, genitourinary, hematopoietic and immunologic, and dermal.
A high-level summary and general conclusions of the preceding toxicology findings.
Identification and qualifications of the individual(s) who evaluated the animal safety data and concluded that it is reasonably safe to begin the proposed human study. This person(s) should sign the summary attesting that the summary accurately reflects the animal toxicology data from the completed studies.
A statement of where the animal studies were conducted and where the records of the studies are available for inspection, should an inspection occur.
According to 21 CFR 312.23(8)(iii) , a statement that the study was conducted in compliance with the good laboratory practices (GLP) in 21 CFR 58 , or, if the study was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance and the sponsor's view on how such noncompliance might affect the interpretations of the findings.

Toxicology: Full Data Tabulation

The sponsor should submit, for each animal toxicology study that is intended to support the safety of the proposed clinical investigation, a full tabulation of data suitable for detailed review. This should consist of line listings of the individual data points, including laboratory data points, for each animal in these trials along with summary tabulations of these data points. To allow interpretation of the line listings, accompanying the line listings should be either: 1) a brief description (i.e., a technical report or abstract including a methods description section) of the study, or 2) a copy of the study protocol and amendments.

Previous Human Experience

A summary of previous human experience with the drug known to the applicant should be included in this section. If the drug(s) is already marketed in the US, then it may be possible to simply refer to the product labeling. There is no specific format for describing previous human experience with an investigational drug in an IND application. If the drug is a combination of drugs previously investigated or marketed, the information should be provided for each active drug component. However, if any component in such combination is subject to an approved marketing application or is otherwise lawfully marketed in the United States, the sponsor is not required to submit published material concerning that active drug component unless such material relates directly to the proposed investigational use (including publications relevant to component- component interaction). If there is no data on previous human experience for this drug, a statement should be inserted reflecting this under each subheading.

Marketed Experience

This section should provide an overview of the FDA-approved indications for the study drug if it is a commercial product. Reference to the FDA drug labeling for approved indications should be noted here. If the drug was withdrawn from the market for any reason related to safety or effectiveness, identification of the country(ies) where the drug was withdrawn and the reasons for withdrawal should be included.

Prior Clinical Research Experience

If the drug has been the subject of controlled trials, detailed information on trials that are relevant to an assessment of the drug's effectiveness for the proposed investigational use(s) should be provided. Any published material that is relevant to the safety of the proposed investigation or to an assessment of the drug's effectiveness for its proposed investigational use should be provided in full. Published material that is less directly relevant may be supplied by a bibliography.

If there has been no previous human experience, the submission should so state.

Clinical Care Experience

It is not uncommon for marketed drugs to be used in clinical care settings to treat patients for indications that do not have an FDA approval. This is often termed "off-label" use. Any published literature on the safety of the drug in that setting, and if available, published practice guidelines of the use of the drug for standard-of-care and the associated safety information could be referenced here. This is particularly relevant if the patient population treated with this off-label use of the drug is similar to the proposed study population for this IND application.

References used should be listed in this section. Complete reprints of select articles may be provided to aid the FDA reviewers, limited to two to three reprints. FDA does not have access to all journal articles and so including selected reprints can help facilitate the review of an IND application.

Disclosure of Financial Interests

IND sponsors are not required to submit information regarding clinical investigator financial interests or arrangements in IND applications. They are, however, required to collect this information before a clinical investigator participates in a clinical study and clinical investigators are required to disclose financial information to sponsors. The information does not need to be submitted to FDA until a marketing application is submitted containing the results of the covered clinical study.

In the interest of collecting this information at the initial stage of an IND, clinical investigators may also complete a Form FDA 3454 if they have no financial interests or arrangements to disclose, or Form FDA 3455 to disclose the nature of their interests and arrangements.

Additional Information

In certain applications, as described below, information on special topics may be needed. Such information shall be submitted in this section as outlined below.

Otherwise you may simply state 'not applicable'.

Drug Dependence and Abuse Potential

If the drug is a psychotropic substance or otherwise has abuse potential, a section describing relevant clinical studies and experience and studies in test animals should be included.

If this section is relevant to your investigation, please see Guidance for Industry – Assessment of Abuse Potential of Drugs .

Radioactive Drugs

If the drug is a radioactive drug, sufficient data from animal or human studies should be provided, to allow a reasonable calculation of radiation-absorbed dose to the whole body and critical organs upon administration to a human subject. Phase 1 studies of radioactive drugs must include studies which will obtain sufficient data for dosimetry calculations.

If this section is relevant to your investigation, please see Medical Imaging and Drug Development .

Pediatric Studies

If the investigational drug will be studied in pediatric setting, plans for assessing pediatric safety and effectiveness should be provided.

If this section is relevant to your investigation, please see Pediatric Product Development .

Other Information

A brief statement of any other information that would aid evaluation of the proposed clinical investigations with respect to their safety or their design and potential as controlled clinical trials to support marketing of the drug should be included in this section.

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Initial IND submission

IND Template

Video explanation

This initial IND submission template is designed for sponsor-investigators conducting 'simple' clinical studies where commercially marketed drugs are being evaluated.

Maintain all of the headings in this document. If some are not applicable, simply state this under the appropriate headings.

Form FDA 1571 - IND Application

Current version of Form FDA 1571 Form FDA 1571 Instructions

What is the FDA 1571 form?

Form FDA 1571 is used for two purposes: 1) to obtain agreement from the sponsor (or sponsor-investigator) to conduct research according to all appropriate FDA regulations; and 2) to serve as a cover sheet for all submissions to the FDA on behalf of a particular IND.

When is the FDA 1571 necessary?

Form FDA 1571 should be completed for every submission sent to the FDA on behalf of a particular IND.

What information do I need to fill out the Form FDA 1571?

Include the following information on Form FDA 1571:

Contact information and mailing address of the sponsor (or sponsor-investigator)

IND number, if it has been issued

Serial number (see below)

The name(s) of the drug/biologic and the indication being studied

The contents of the submission

Name and title of the individuals responsible for monitoring the study and reviewing safety data.

What is the serial number in box 10?

Each submission to the FDA regarding a particular IND is given a consecutive serial number. The initial submission will be 0000, and all subsequent correspondence will have a new serial number (0001, 0002, etc.)

Form FDA 1572

Frequently Asked Questions – Statement of Investigator (Form FDA 1572)) Current version of Form FDA 1572 Form FDA 1572 Instructions

The intent of the Form FDA 1572 is two-fold. It is a signed agreement from the Investigator that he/she will conduct the research in compliance with FDA regulations. Additionally, it collects all the clinical site and investigator information needed by the sponsor (or sponsor-investigator) to assure the FDA that all investigators have the experience and background needed to conduct the trial. The sponsor of the study is responsible for ensuring that updated Form FDA 1572 is submitted to the FDA. The site investigator is responsible for updating his/her Form FDA 1572 and providing it to the sponsor in a timely manner so the information can be sent to the FDA.

When is the Form FDA 1572 necessary?

When filing an Initial IND Submission, a completed Form FDA 1572 must be sent from each site.

When adding a new investigator (or new site), or replacing an investigator at an existing site. Note: a Form FDA 1572 must be submitted to the FDA within 30 days of the investigator being added.

When changing any site information: IRB, laboratory, or clinical site.

What information do I need to fill out the Form FDA 1572?

A current CV or statement of qualifications of the investigator listed on the Form FDA 1572. It does not need to be signed.

Name and address of the location where the clinical investigation will be conducted, the clinical laboratories that will be used, and the IRB reviewing the study.

Names of the sub-investigators at the site

Form FDA 3674 - Certification of Compliance

Current version of Form FDA 3674 Adobe Reader may be needed to view this document Form FDA 3674 Instructions

The FDA form 3674 is a document that must accompany all FDA IND initial submissions and submission of new protocols to INDs. It is a signed statement from the sponsor-investigator that they will comply with clinicaltrials.gov requirements concerning their investigation.

BOX A Should be checked if there is not a clinical investigation covered in the IND submission.

BOX B Should be checked if there is a clinical investigation, but the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act do not apply. This is the case for most Phase I studies.

BOX C Should be checked if there is a clinical investigation and the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act do apply. By checking this box, the investigator certifies that they will comply with those requirements.

If a clinical trial is funded all or in part through the NIH, it is a federal requirement that the human clinical trial be registered on clinicaltrials.gov .

Please see FDAAA 801 Requirements at clinicaltrials.gov for more information.

Cover Letter

The cover letter is the first piece of information that the FDA sees upon receipt of an Initial IND submission. It expresses the intent of the sponsor-investigator to request FDA review of the enclosed information, and briefly describes the proposed research.

Items to include in the cover letter:

The cover letter should be on departmental letterhead

Title the cover letter: "Initial Investigational New Drug Application"

Brief explanation of the investigation (i.e., use the study title)

Disease or condition being studied

Name, formulation, and proposed dose of drug product.

Contact information (phone, email, address) of the sponsor-investigator and (recommended) a designated individual authorized to interact with the FDA on the sponsor-investigator's behalf.

More about the cover letter

Keep cover letter short, ~ 1-2 pages.

For a Drug:

For a Therapeutic Biological Product:

For a Biological Product:

Ensure the date of the cover letter matches the date on the signed copy of Form FDA 1571.

If the sponsor-investigator and FDA have already had a Pre-IND meeting, then this should be noted in the letter, and reference the PIND number and date of meeting.

Refer to sample cover letter, see below. The text is intended to provide a general example of the flow of a cover letter. It can be changed to fit the particular needs of different studies.

IND Cover Letter Template

Letter of Support / Authorization

If a sponsor-investigator is proposing to evaluate a drug that is the subject of an existing IND (being developed by a commercial sponsor), they can request a letter of cross-reference authorization from the sponsor of that IND. This permits the sponsor-investigator to refer the FDA to the information contained in the commercial sponsor's IND, and maintain the confidentiality of their proprietary information. The FDA can use the original IND material, along with their own internal reviews of that material to assist in their review process.

Additionally, an IND for a drug that has been approved by the FDA for commercial use, may require more information than what is provided in the package insert. Again, the sponsor-investigator may request a letter of cross-reference authorization from the commercial sponsor.

Commercial sponsors should provide the IND, NDA, or BLA file name, reference number, volume, and page numbers where the FDA can find the information relevant to the sponsor-investigator's IND application.

Sections of an IND submission

Refer to FDA's Guidance entitled Investigational New Drug Applications Prepared and Submitted by sponsor-investigators for more information.

Introduction

Introductory statement.

Briefly describe the research plan submitted in this IND. This section should be 2-3 pages long. This should include a brief discussion of the disease state to be assessed. The intent of this section is to place the use of the drugs with this indication into perspective for the FDA. Refer to 21 CFR 312.23(a)(3)

Name of the Drug and All Active Ingredients

Include all known names of the drug: generic and marketed names, chemical name.

Pharmacological Class of the Drug

Include the pharmacological class of the drug.

Structural Formula of the Drug

Both the structural and chemical formulas should be here.

This section may not be applicable to biologics. You could describe the protein or complex of proteins instead (e.g. 341 amino acids with a molecular weight of 150 g/mol)

Formulation of the Dosage Form(s) to be Used

Include a brief description of the formulation and dosage. Describe formulations/dosages of every active component of a combination therapy.

Include placebo information, if applicable.

Route of Administration

Briefly describe the route of administration and the planned exposure (ie duration of study drug administration).

Objectives and Duration of the Proposed Clinical Investigation(s)

If more than one protocol is being submitted under this IND, detail each separately, and clearly indicate that there is more than one planned investigation.

Summary of Previous Human Experience

This is a brief summary of previous human experience with the drug(s), with reference to the relevant literature or other INDs, if pertinent. Also, investigational or marketing experience in other countries may be relevant to the safety of the proposed clinical investigation(s). This topic will be written up in detail in the Previous Human Experience section; however, for many sponsor-investigator INDs that use commercially available drugs, the summary included in the Introduction and Previous Human Experience section are often identical.

If an IND application or other document previously submitted to the FDA is to be referenced, then the sponsor must identify the file/document by: Name Reference number Volume Page number where the information may be found

In order to reference an IND application previously submitted by others (i.e. other sponsor's INDs), such a reference is required to contain a written statement that authorizes the reference and that is signed by the person who submitted the referenced information.

Status of Drug in Other Countries

This section is likely not applicable to a standard sponsor-investigator IND submission. If the drug has been withdrawn from investigation or marketing in any country for any reason related to safety or effectiveness, identification of the country(ies) where the drug was withdrawn and the reasons for the withdrawal are stated here. For a sponsor-investigator IND, you may simply state you are not aware of any withdrawals.

List any references used in this section.

General Investigational Plan

As the studies contained in this IND progress from phase 1 to phases 2 and 3, the contents of this section will change. For the purpose of the initial submission, provide information that will be relevant for the first year of investigation. Changes to the plan and additional protocols can be included in future annual reports and amendments.

The rationale for the drug and/or research study. Provide enough background information on the topic for the FDA to understand the scientific justification for the investigation.

Indication to be Studied

Identify the indication to be studied in this investigation. Describe sub-sets of a more general study population if needed.

General Approach for Evaluation of Treatment

Provide a high-level description of data to be collected and its use in evaluation of the efficacy of the intervention being studied.

Description of First Year Trial(s)

The FDA understands that study plans may change over time. In this section provide a high-level description of the plan for the first 12 months of clinical investigation.

Number of Subjects to be Evaluated

Provide the planned number of subjects to be enrolled in the first year of IND activity.

Drug Related Risks

Any risks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug(s) or related drugs. Include any study procedures that carry risks of more than minimal severity.

Investigator Brochure

For sponsor-investigator initiated INDs, there is no requirement to produce an Investigator Brochure if you have a single site study. You may incorporate the following statement:

If an approved drug is being investigated, then it is appropriate to refer to the labeling and provide a URL link to the most current product label. You may find these links useful for finding current product labeling:

Drugs@FDA: FDA Approved Drug Products

You may also reference Letters of Authorization in this section.

Multi-Site Investigations

If there will be a multi-center (external site) clinical investigation under a University-based, sponsor-investigator IND application, an Investigator's Brochure should be developed for dissemination to each of the involved study sites and should address the following information:

A brief description of the active drug substance and the drug product formulation, including the structural formula of the active drug substance, if known.
A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
A summary of the pharmacokinetics and biological distribution of the drug in animals and, if known, in humans.
A summary of information relating to the safety and effectiveness of the drug in humans obtained from prior clinical studies. (Reprints of published articles describing such studies may be appended to the Brochure if they are anticipated to be useful.)
A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug.

Proposed Clinical Research

Provide a protocol and informed consent document for each planned study.

Study Protocol

The NIH and FDA have developed a protocol template with guidance and example text to assist investigators when applying for an IND.

Refer to 21 CFR 312.23(6) for complete protocol requirements. The general summary of the overall research plan should be followed by the "Executive Summary" section(s) of the protocol template (or some similar brief protocol summary) for each protocol to be included in this IND application. The actual full protocol(s) is/are to be included as an attachment to this application (see last section below describing attachments).

Due to the unpredictable nature of Phase 1 studies, Phase 1 protocols can be flexible and more focused on providing a general outline of the clinical investigation (dosing plan, safety precautions). Additionally, following IND approval, changes to Phase 1 protocols that do not affect the safety of subjects need only be included in IND annual reports, not more frequent amendments.

The main components of a clinical protocol are described in Guidance for Industry – E6 Good Clinical Practice: Consolidated Guidance . Some of the information listed in this guidance document may be contained in other protocol referenced documents, such as the IB.

The NIH-FDA Protocol Template is a highly recommended template that guides investigators through the information that should be included in a protocol.

Informed Consent

Informed consent documents (ICD) do not need to be included in the IND submission, but it is recommended that they be included. If a sponsor does not submit an ICD as part of its IND submission, the review division may request and review the ICD at any time. The request will reference 21 CFR 312.23(a)(11) , which states that if requested by the FDA, the sponsor must submit "any other relevant information needed for review of the application."

Informed consent documents are institution-specific but all forms will address the same required topics. Some guidelines are listed below to assist in drafting an informed consent document:

Informed Consent Checklist

A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject's participation
A description of the procedures to be followed
Identification of any procedures which are experimental (i.e., not standard of care)
A description of any reasonably foreseeable risks or discomforts to the subject (ideally subdivided by frequency and severity)
A description of any benefits to the subject or to others which may reasonably be expected from the research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
An explanation of whom to contact for answers to pertinent questions about research subjects' rights, about the research and in the event of research-related injury.
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
Include clinicaltrials.gov language
FDA-regulated clinical investigations: Subjects must be informed that the FDA may inspect the records of the study.
A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
Any additional costs to the subject that may result from participation in the research
The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
Statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
The approximate number of subjects involved in the study
A clear description of the operation of the bio-specimen resource. This description could include details that may be of interest to human research participants, such as whether identifiable information will be maintained by the bio-specimen resource and/or whether research results will be linked to the bio-specimen.
The conditions under which samples and data will be released to recipient investigators. Procedures for protecting the privacy of human research participants and confidentiality of data.
Specific descriptions of the nature and purpose of the research.
Information about the consequences of DNA typing if human genetic research is anticipated.
Specific and meaningful description of what will be used or disclosed.
The name or other specific identification of the person, or class of persons, authorized to make the use or disclosure.
The name or other specific identification of the person, or class of persons, to whom the covered entity may make the requested use or disclosure.
A description of each purpose of the requested use or disclosure.
An expiration date/expiration event that relates to the individual or the purpose of the use or disclosure.
Statement regarding the right of the individual to revoke the authorization in writing, and the limits of that right.
Statement regarding the right of the individual to refuse to sign authorization
Statement regarding ability or inability to condition treatment, payment, enrollment or eligibility for benefits on the authorization
Re-disclosure Statement - Information disclosed to others not subject to the Privacy Rule may be re-disclosed by them without the Privacy Rule protections (cannot promise that information will definitely be protected)

Disclaimer:

Informed Consent documents should be written in such a way that they can be understood by the general public. Language should be targeted at a 5th grade reading level. It is advisable to keep the document concise for the benefit of the reader.

If the investigation involves an exception from informed consent requirements, this should be stated and the reasoning explained.

For more detailed information on informed consent regulations, check Guide to Informed Consent - Information Sheet .

Investigator and Facilities Data

Provide the name, address, and a statement of the qualifications (curriculum vitae or other statement of qualifications) of each investigator as well as the name of each sub-investigator (i.e., research fellow, resident) working under the supervision of the investigator. Also needed are the name(s) and address(es) of the research facility(ies) to be used as well as the name and address of each reviewing Institutional Review Board (IRB).

The information needed for this section is provided to the FDA on the Form FDA 1572 along with copies of the sponsor-investigator's CV, medical license, and financial disclosure forms (Form FDA 3454 and Form FDA 3455; see below for additional guidance). While not required, the sponsor-investigator may also provide copies of the CVs, medical or other professional licenses (if applicable), and financial disclosure forms (Form FDA 3454 and Form FDA 3455) for all sub-investigators listed in Box 6 of the Form FDA 1572. If the sponsor-investigator chooses not provide the sub-investigators' information in the application, the applicant MUST maintain copies of this documentation in an IND regulatory binder. Additional guidance on the completion of the FDA forms for this section as well the website where fillable PDF forms can be found are provided below.

The FDA forms, CVs, and licenses may either 1) be placed after the appropriate subheading in this section or 2) placed in the Attachments.

Insert completed Form FDA 1572, or indicate "Signed and dated Form FDA 1572 in Attachments."

Disclosure of Financial Interests

Form FDA 3454

In the interested of collecting this information at the stage of an IND, clinical investigators could complete a Form FDA 3454 if they have no financial interests or arrangements to disclose or Form FDA 3455 to disclose the nature of their interests and arrangements.

For more information, see FDA's Guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators .

Chemistry, Manufacturing and Control Information

Chemistry, manufacturing and control.

If the investigational drug has been marketed, this section may be covered by referring to the product labeling. You may refer back to the URL identified in the Investigator's Brochure section. Alternatively, it might be appropriate to refer to a 'Letter of Authorization' if using a drug provided by a commercial company.

This section describes the composition, manufacture, and control of the drug substance and the drug product according to 21 CFR 312.23(7) . Note: Reference to the current edition of the United States Pharmacopoeia – National Formulary may satisfy relevant requirements in this section.

Drug Substance

Description of drug; include physical, chemical, or biological characteristics and evidence supporting structure and identity of the active pharmaceutical ingredient(s)
Name and address of manufacturer of drug product
Description of the general method of preparation of the drug substance, including a list of the reagents, solvents, and catalysts used. A detailed flow diagram is suggested as the most effective presentation. More information may be needed to assess the safety of biotechnology-derived drugs or drugs extracted from human or animal or plant sources
The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug substance, with a brief description of the test methods used (i.e., Nuclear Magnetic Resonance, Infrared, UV spectra to prove the identity, and High Performance Liquid chromatograms to support the purity level and impurities, etc.). Submission of certificates of analysis is also suggested.
Information to support stability of the drug substance during storage in the intended container closure and during the toxicological and clinical studies

Drug Product

List all components used in the manufacture of the investigational drug product, including both those components intended to appear in the drug product and those which may not appear but which are used in the manufacturing process
Where possible, the quantitative composition of the investigational drug product, including any reasonable variations that may be expected during the investigational stage
Brief general description of the manufacturing process (in the form of a flow diagram is suggested) and packaging procedure, as well as other relevant tests, as appropriate for the product. Final specifications for the drug product intended to be used in toxicological and clinical studies should be included. For injectable products, sterility and pyrogenicity tests, endotoxin levels and particulate matter should be included. Submitting a copy of the certificate of analysis of the clinical batch is also suggested. Information sufficient to assure the product's stability during the planned clinical studies.
The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug product
Information to support stability of the drug product during the planned clinical studies

Placebo Product

Note: Delete this section if not applicable

Include a brief general description of the composition, manufacture, and control of any placebo used in the controlled clinical trial.

Include copies of the label constructed for the study drug and any associated package.

Note: Labels must contain the phrase: "Caution: New Drug - Limited by Federal law to investigational use".

Environmental Assessment

Insert the statement below, unless there is a reason to believe the distribution and use of the drug could have an environmental impact. The FDA may require an environmental analysis to ensure the study agent does not impose an undue environmental hazard {21 CFR 312.23(7)(e) }. For products already marketed, it may be possible to request and exemption from the requirement to conduct an environmental analysis. Details around the expectation of the FDA for this section should be discussed in the pre-IND meeting held between the sponsor-investigator and the FDA to discuss the IND application.

For more detailed information, take the FDA "Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND" Training Course .

Pharmacology and Toxicology Information

As was true for the Chemistry, Manufacturing and Controls section, you may use an authorization letter(s) or cite the drug label to satisfy this section.

Per 21 CFR 312.23(8) , this section is expected to include information about pharmacological and toxicological (laboratory animals or in vitro) studies on the basis of which the sponsor of the IND application has concluded that it is reasonably safe to conduct the proposed clinical investigations. The kind, duration, and scope of animal and other studies required in the application will depend on the duration and nature of the proposed clinical investigations. For recommendations regarding study types and duration, refer to the FDA Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorizations for Pharmaceuticals .

Compliance with Good Laboratory Practice (GLP) is generally expected for pivotal in vitro and in vivo studies submitted in support of an IND application. For each non-clinical laboratory study subject to the GLP regulations, investigators are expected to state in the study report that the study was conducted in compliance with the GLP regulations. If the study was not conducted in compliance with the GLP regulations, investigators should submit a brief statement of the reason for noncompliance. FDA Guidance documents relevant to Pharmacology and Toxicology information are available at the FDA website.

The IND sponsor should also provide a statement describing where the non-clinical investigations were conducted and the location of all records available for inspection.

Pharmacology and Drug Distribution

Description of the pharmacologic effects and mechanism(s) of actions of the drug in animals
Information on the absorption, distribution, metabolism, and excretions of the drug

Pharmacology Summary and Conclusions

Toxicology: integrated summary.

Expected content elements for describing specific toxicology studies for this section typically include:

Study title
Study drug formulation/vehicle
Brief description of the design of the trials
Systematic presentation of the findings from the animal toxicology and toxicokenetic studies. The format of this part of the summary may be approached from a "systems review" perspective: i.e. CNS, cardiovascular, gastrointestinal, renal, hepatic, genitourinary, hematopoietic and immunologic, and dermal.
Provide high-level summary and general conclusions of the preceding toxicology findings.
Identification and qualifications of the individual(s) who evaluated the animal safety data and concluded that it is reasonably safe to begin the proposed human study. This person(s) should sign the summary attesting that the summary accurately reflects the animal toxicology data from the completed studies.
A statement of where the animal studies were conducted and where the records of the studies are available for inspection, should an inspection occur.
According to 21 CFR 312.23(8)(iii) , a statement that the study was conducted in compliance with the good laboratory practices (GLP) in 21 CFR 58 , or, if the study was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance and the sponsor's view on how such noncompliance might affect the interpretations of the findings.

Toxicology: Full Data Tabulation

Previous Human Experience

A summary of previous human experience with the drug known to the applicant. If the drug(s) is already marketed in the US, then you may be able to simply refer to the product labeling.

There is no specific format for describing previous human experience with an investigational drug in an IND application; however, the FDA website provides helpful points to consider when writing a summary of previous human experience .

If the drug is a combination of drugs previously investigated or marketed, the information should be provided for each active drug component. However, if any component in such combination is subject to an approved marketing application or is otherwise lawfully marketed in the United States, the sponsor is not required to submit published material concerning that active drug component unless such material relates directly to the proposed investigational use (including publications relevant to component- component interaction).

If there is no data on previous human experience for this drug, insert a statement reflecting that under each subheading.

Marketed Experience

Overview any FDA-approved marketed indications for the study drug. Reference to the FDA drug labeling for approved indications should be noted here.

Prior Clinical Research Experience

If the drug has been the subject of controlled trials, detailed information on trials that are relevant to an assessment of the drug's effectiveness for the proposed investigational use(s) should also be provided. Any published material that is relevant to the safety of the proposed investigation or to an assessment of the drug's effectiveness for its proposed investigational use should be provided in full. Published material that is less directly relevant may be supplied by a bibliography.

If there has been no previous human experience, the submission should so state.

Clinical Care Experience

Note: Delete this sub-section if not applicable.

List any references used in this section. Complete reprints of select articles may be provided to aid the FDA reviewers, but do not attach more than two to three reprints. Remember that FDA does not have access to all journal articles and so including selected reprints can help facilitate the review of an IND application.

Additional Information

In certain applications, as described below, information on special topics may be needed. Such information shall be submitted in this section as outlined below. Otherwise you may simply state 'not applicable'.

Drug Dependence and Abuse Potential

If the drug is a psychotropic substance or otherwise has abuse potential, a section describing relevant clinical studies and experience and studies in test animals.

If this section is relevant to your investigation, please see Guidance for Industry – Assessment of Abuse Potential of Drugs .

Radioactive Drugs

If this section is relevant to your investigation, please see Medical Imaging and Drug Development .

Pediatric Studies

If the investigational drug will be studied in pediatric setting, plans for assessing pediatric safety and effectiveness should be provided.

If this section is relevant to your investigation, please see Pediatric Product Development .

Other Information

Selected References

If you are including reprints with your submission, list them in this section.

Relevant Information

If requested by FDA, any other relevant information needed for review of the application.

Submission Formatting

Commercial INDs, where the sponsor intends to conduct clinical research to support a future marketing application, must be submitted electronically in Common Technical Document format (eCTD) through the FDA Electronic Submissions Gateway (ESG) . However, research INDs, where the sponsor intends to conduct clinical research for publishing and general knowledge and does NOT intend to commercialize the product, are not required to be submitted in eCTD format and may be submitted on paper as described below. Additionally, research INDs can be submitted electronically through the ESG in either eCTD or non-eCTD format. Research INDs reviewed by CDER can also be submitted electronically through the CDER NextGen Portal .

General Formatting Guidelines for Paper Submissions

Use 1 ½" left margin to allow for binding space. FDA prefers 12pt font, but smaller fonts will still be accepted. The font should be consistent throughout the entire submission. Use black typeface, with standard blue formatting for hyperlinks if included. Any pictures should be printed in color.

Three copies (original and 2 exact copies) must be sent to the FDA at the appropriate address below:

A "courtesy e-copy" may be sent as well. The e-copy should be an exact copy of the original, in PDF format. If use of multimedia is necessary for the submission (i.e. large detailed images, or videos), then the submission cover letter should indicate the additional information contained on the e-copy. The e-copy is submitted on a CD, DVD, or thumb drive. Make sure that the information is not encrypted, or accompanied by loading software (especially common on thumb drives). Ensure that the e-copy is secured in a pocket page divider and has a label just like the paper submissions. (See below)

The paper submissions should be bound individually in 3-hole punch ACCO-style folders. The original submission should be in a gray folder. The other two copies may be in different colors. Submissions that are inadequately bound will not be reviewed.

A label should be attached to the front of each folder. If more than one volume is needed, indicate the volume number on the folder. The e-copy should have a label.

Headers and Footers

Top Left <Name of Investigation, Initial IND>

Top Right Sponsor: <Name of sponsor-investigator>

Bottom Left <University> Confidential and Proprietary

Bottom Right <Page Number>

Bioprocessing
Chromatography
Drug Delivery
Formulation Development
Microbiology
Spectroscopy

FDA Publishes Guidance for industry: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions

On June 5, 2023, FDA published the guidance for industry titled “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions,” which was published as a draft in December 2021. This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.

Cover letters provide an overview of a submission and help FDA ensure that the submission is properly triaged and assigned to the appropriate assessors. In an effort to ensure that submissions are effectively managed by FDA and acted upon within the performance revew goal dates agreed to in the GDUFA III commitment letter, FDA has developed cover letter attachments to accompany, or assist in the preparation of, applicants’ cover letters for the common submissions listed above. These attachments do not replace cover letters.

These cover letter attachments have been designed as a checklist to reflect common types of information applicants are expected to address in their cover letters. The attachments are intended to serve as a useful guide to help applicants prepare their cover letters and to assist FDA in the triage and management of submissions.

FDA published this guidance as part of its GDUFA III commitments and in support of the Drug Competition Action Plan (DCAP), which seeks to foster generic competition and help address the high cost of drugs. Through DCAP, FDA is committed to enhancing the efficiency of the development and approval of ANDAs, with the ultimate goal of more approvals, thereby helping to increase access to high-quality, lower cost generic drugs.

Additional Resources

Controlled Correspondence – Resources for correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or certain post-approval submission requirements

ANDA Forms and Submission Requirements – Summary tables, application forms, question-based review, and other resources related to ANDA submissions

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Cover Letter Attachments for Controlled Correspondence and Abbreviated New Drug Application Submissions; Guidance for Industry; Availability

A Notice by the Food and Drug Administration on 06/06/2023

This document has been published in the Federal Register . Use the PDF linked in the document sidebar for the official electronic format.

Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2021-D-0861 Document Citation 88 FR 37069 Document Number 2023-11943 Document Type Notice Pages 37069-37070 (2 pages) Publication Date 06/06/2023 Published Content - Document Details
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Cover Letter Attachments for Controlled Correspondences and ANDA Submissions; Draft Guidance for Industry; Availability

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Department of Health and Human Services

Food and drug administration.

[Docket No. FDA-2021-D-0861]

Food and Drug Administration, HHS.

Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. This guidance finalizes the draft guidance of the same title issued on December 13, 2021.

The announcement of the guidance is published in the Federal Register on June 6, 2023.

You may submit either electronic or written comments on Agency guidances at any time as follows:

Submit electronic comments in the following way:

Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov .
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Submit written/paper submissions as follows:

Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2021-D-0861 for “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed ( print page 37070) except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469 , September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf .

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5) ).

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Jonathan Hughes, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 1668, Silver Spring, MD 20993-0002, 240-702-3970, [email protected] .

FDA is announcing the availability of a guidance for industry entitled “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” This guidance is intended to assist prospective applicants, applicants, and holders of ANDAs with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.

A cover letter is generally included with controlled correspondence to the Office of Generic Drugs and submissions to an ANDA file. While a cover letter is not required content for an ANDA, the cover letter is a part of the electronic common technical document hierarchy and is included in Module 1 of an ANDA submission.

The cover letter provides an overview of the submission and helps FDA ensure that the submission is properly triaged and assigned to the appropriate assessors. In an effort to ensure that submissions are effectively managed by FDA and acted upon within the performance review goal dates reflected in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 commitment letter (GDUFA III Commitment Letter), [ 1 ] FDA has developed cover letter attachments to accompany, not replace, applicants' cover letters for common submissions, including controlled correspondence, original ANDAs, and amendments to ANDAs, as well as supplements to approved ANDAs. These cover letter attachments have been designed as a checklist to reflect common types of information applicants are expected to address in their cover letters. The attachments are intended both to serve as a useful guide to help applicants prepare their cover letters and to assist FDA in the triage and management of submissions.

This guidance finalizes the draft guidance entitled “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions” issued on December 13, 2021 ( 86 FR 70849 ). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include clarifying that use of the cover letter attachments are voluntary; defining several terms that may have been ambiguous ( e.g., “administrative general correspondence” and “approved citizen petitions”); and adding updated information on labeling carve-outs and requests for reconsideration. In addition, editorial changes were made to improve clarity, such as adding lines to denote where information should be filled in by the applicant and minor reformatting of the attachments in the appendices.

This guidance is being issued consistent with FDA's good guidance practices regulation ( 21 CFR 10.115 ). The guidance represents the current thinking of FDA on “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) ( 44 U.S.C. 3501-3521 ) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 (including subpart C) for to the content and format of ANDAs, including original ANDAs, amendments to ANDAs, and supplements to approved ANDAs, submitted by applicants and approved by FDA have been approved under OMB control number 0910-0001. The collections of information for Form FDA 356h (NDA and ANDA cover letter) have been approved under OMB control number 0910-0338.

Applicants submit to FDA controlled correspondence along with cover letters related to generic drug development and FDA approval. The collections of information for such submissions have been approved under OMB control number 0910-0797. The collections of information in 21 CFR part 11 for electronic records and electronic signatures have been approved under OMB control number 0910-0303. The collections of information in 21 CFR part 211 about the manufacture of the drug have been approved under OMB control number 0910-0139.

Persons with access to the internet may obtain the final guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs , https://www.fda.gov/regulatory-information/search-fda-guidance-documents , or https://www.regulations.gov .

Dated: May 31, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

1. Available at: https://www.fda.gov/media/153631/download .

[ FR Doc. 2023-11943 Filed 6-5-23; 8:45 am]

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Written Samples

15 sample cover letters for work study position.

You’ve found the perfect work-study position to help pay for college expenses while gaining valuable real-world experience.

But before you can land the job, you need to write a compelling cover letter that will make you stand out from the competition.

Cover letters are your chance to sell yourself to potential employers, highlighting your relevant skills, experiences, and enthusiasm for the role.

But knowing what to say and how to say it can be tricky, especially if you’re new to the job market.

Sample Cover Letters for Work Study Position

To help you get started, we’ve compiled 15 sample cover letters specifically tailored for work-study positions.

These examples cover a range of industries and job types, from office assistants to lab technicians to social media interns.

Use these samples as inspiration for structuring and wording your unique cover letter.

Customize them with your details and personality to create a letter that truly represents you and your fit for the position.

Ready to get noticed and get hired?

Let’s dive into our 15 standout sample cover letters for work-study roles.

Subject: Application for Marketing Assistant Work Study Position

Dear Hiring Manager,

I am excited to apply for the Marketing Assistant work-study position at XYZ Company. As a sophomore majoring in Marketing at ABC University, I am eager to gain hands-on experience in my field while contributing my skills and enthusiasm to your marketing team.

In my coursework, I have developed a strong foundation in marketing principles, market research, and digital marketing strategies. I have also honed my communication, organization, and project management abilities through various group projects and presentations.

Additionally, I bring relevant experience from my role as Social Media Coordinator for our university’s Business Club. In this position, I created engaging social media content, monitored and responded to comments and messages, and helped grow our follower base by 25% over two semesters. I am confident I can apply these same skills to support your company’s marketing initiatives.

I am impressed by XYZ Company’s innovative products and commitment to sustainability. I would welcome the opportunity to learn from your expert team while providing quality work to support your marketing goals. My strong work ethic, adaptability, and eagerness to learn make me a great fit for this role.

Thank you for considering my application. I have attached my resume for your review. I look forward to discussing my qualifications further in an interview.

[Your Name]

Subject: Application for Research Assistant Work Study Position

Dear Dr. Johnson,

I am writing to apply for the Research Assistant work-study position in your biology lab at XYZ University. As a junior Biology major with a 3.8 GPA, I am well-prepared and passionate about gaining research experience alongside your expert team.

In my upper-level biology lab courses, I have gained extensive experience with common lab techniques including micro pipetting, gel electrophoresis, PCR, and cell culture. I am detail-oriented, meticulous in my work, and quick to master new protocols. My strong analytical and problem-solving skills will enable me to contribute effectively to your research projects.

Additionally, I served as a teaching assistant for Introductory Biology last semester. In this role, I guided students through experiments, answered questions, and graded lab reports. This experience strengthened my communication and leadership abilities, which I can apply to collaborating with your research team and mentoring incoming students.

I have a long-standing interest in your lab’s research into the molecular basis of Parkinson’s disease. I am eager for the chance to contribute to this vital work while developing my research skills under your mentorship. I am reliable, hardworking, and committed to conducting high-quality research.

Thank you for considering my application. I have attached my resume and a faculty recommendation. I would welcome the chance to discuss my qualifications and enthusiasm for this position in more detail.

Subject: Application for Graphic Design Intern Work Study Position

Dear Ms. Thompson,

I am thrilled to apply for the Graphic Design Intern work-study position at ABC Creative Agency. As a senior Graphic Design major with a passion for branding and print design, I am excited by the opportunity to apply my skills in a fast-paced agency setting.

Through my coursework and design projects, I have developed advanced proficiency in Adobe Creative Suite, particularly InDesign, Illustrator, and Photoshop. I have experience designing logos, brochures, posters, packaging, and other print materials for a variety of client types. I pride myself on my creativity, attention to detail, and ability to translate client needs into impactful designs.

I also bring relevant experience from my freelance design work, where I have collaborated with several small businesses and campus organizations. Through these projects, I have honed my skills in client communication, project management, and working efficiently to meet deadlines. I am confident I can apply these same strengths to support your design team and clients.

I am drawn to ABC Creative Agency’s inventive designs and commitment to delivering top-notch creative solutions. I would relish the chance to learn industry best practices from your talented team while utilizing my design capabilities to create memorable, effective materials for your clients.

Thank you for considering my application. I have attached my resume and design portfolio for your review. I look forward to the opportunity to discuss how I can contribute to ABC Creative Agency as your next Graphic Design Intern.

Subject: Application for Accounting Clerk Work Study Position

I am writing to apply for the Accounting Clerk work-study position at XYZ Corporation. As an Accounting major entering my junior year, I am excited to apply my classroom learning in a corporate accounting setting while providing diligent support to your accounting team.

In my accounting coursework, I have developed a strong foundation in financial accounting principles, managerial accounting, and tax accounting. I have experience preparing and analyzing financial statements, ledger reconciliations, and tax documents. I am highly organized, detail-oriented, and adept with accounting software including Excel, QuickBooks, and TurboTax.

Additionally, I serve as Treasurer for my university’s Accounting Club. In this role, I oversee the club’s budget, expense tracking, and financial reporting. I have honed my bookkeeping accuracy, financial analysis skills, and ability to communicate financial information. I am confident I can bring these same strengths to the Accounting Clerk position.

I am drawn to XYZ Corporation’s status as an industry leader and its reputation for financial excellence. I would welcome the opportunity to learn accounting best practices from your knowledgeable team while providing quality, thorough work to support the company’s financial functions.

Thank you for considering my application. I have attached my resume for your review. I look forward to discussing my qualifications and enthusiasm for this role in more detail.

Subject: Application for IT Help Desk Work Study Position

Dear Mr. Patel,

I am excited to apply for the IT Help Desk work-study position at ABC University. As a sophomore Computer Science major with a talent for problem-solving, I am eager to apply my technical skills while providing excellent customer service to university students, faculty, and staff.

Through my coursework in programming, databases, and networking, I have developed a broad understanding of computer systems and troubleshooting strategies. I am proficient in common programming languages, operating systems, and productivity software. I am a quick learner, adept at explaining technical concepts, and committed to continuously expanding my IT knowledge.

Additionally, I have customer service experience from my part-time retail job, where I assist customers with product questions, recommend solutions, and process sales. I am patient, an active listener, and skilled at resolving customer issues with a positive attitude. I am confident my blend of technical and interpersonal skills will enable me to excel in the Help Desk role.

I am excited by the prospect of gaining hands-on IT support experience while contributing to the smooth technological operations of the university. I am reliable, hardworking, and committed to providing prompt, effective support to all users.

Thank you for considering my application. I have attached my resume for your review. I would appreciate the opportunity to discuss my qualifications further in an interview.

Subject: Application for Tutoring Center Work Study Position

I am writing to apply for the Tutoring Center work-study position at XYZ University. As a senior Education major with a passion for fostering student success, I am eager to apply my academic knowledge and mentoring skills to support my fellow students.

As an Honors student with a 3.9 GPA, I have excelled in courses across disciplines including math, science, English, and foreign languages. My broad knowledge base, combined with my ability to explain concepts clearly, would enable me to tutor students effectively in a variety of subjects.

Additionally, I have extensive experience working with students through my student teaching placements. I have planned and delivered engaging lessons, worked one-on-one with struggling learners, and honed my ability to adapt my teaching style to meet diverse student needs. I am patient, encouraging, and skilled at building rapport with students to boost their confidence and academic performance.

I am passionate about the Tutoring Center’s mission of providing accessible academic support to ensure the success of all students. I would welcome the chance to apply my instructional skills and content mastery to empower students to reach their full academic potential.

Thank you for considering my application. I have attached my resume and faculty recommendations for your review. I look forward to discussing my qualifications and enthusiasm for this role in more detail.

Subject: Application for Social Media Intern Work Study Position

Dear Ms. Johnson,

I am thrilled to apply for the Social Media Intern work-study position at ABC Company. As a junior Marketing major with a concentration in Digital Marketing, I am eager to apply my skills and creativity to support your social media initiatives.

Through my coursework, I have developed expertise in social media strategy, content creation, and analytics. I am well-versed in major platforms including Facebook, Instagram, Twitter, and LinkedIn, as well as tools like Hootsuite and Sprout Social. I have a keen eye for creating engaging, on-brand content and am skilled at analyzing metrics to optimize performance.

I have honed my social media skills through several projects, including developing a comprehensive social media plan for a local non-profit. My campaign helped the organization increase engagement by 40% and reach 1,000 new Followers. I am confident I can apply these same strategies to amplify ABC Company’s social presence.

Additionally, I bring strong writing, graphic design, and video editing skills that will enable me to craft compelling content for your brand. I am creative, detail-oriented, and adept at tailoring content to different audiences and platforms.

I admire ABC Company’s innovative products and customer-centric focus. I would be thrilled to contribute my social media savvy to help you expand your digital reach, engage customers, and drive business results.

Thank you for considering my application. I have attached my resume and social media portfolio for your review. I look forward to the opportunity to discuss how I can add value to your social media efforts.

Subject: Application for Writing Center Tutor Work Study Position

I am excited to apply for the Writing Center Tutor work-study position at XYZ University. As a senior English major with a 4.0 GPA, I am passionate about writing and eager to share my skills to support other students’ academic success.

In my English coursework and as Editor of the campus literary magazine, I have developed strong expertise in academic writing, research, and the writing process. I excel at crafting clear, persuasive prose and have a keen eye for identifying areas for improvement in structure, style, and mechanics. I am confident in my ability to guide students at all levels to refine their writing skills.

Additionally, I have experience as a peer mentor in the English department, where I review student papers, provide constructive feedback, and explain complex concepts. I am patient, adaptable, and skilled at asking questions to help students clarify their ideas. My approachable demeanor and strong communication skills enable me to connect with students and create a supportive learning environment.

I am excited by the prospect of helping more students become confident, capable writers through the Writing Center’s important work. I am committed to providing individualized guidance to help each student develop and clearly express their unique voice.

Thank you for considering my application. I have attached my resume and writing samples for your review. I would welcome the opportunity to discuss my qualifications and tutoring approach in more detail.

Subject: Application for Campus Tour Guide Work Study Position

Dear Mr. Johnson,

I am thrilled to apply for the Campus Tour Guide work-study position at ABC University. As a junior Communication Studies major with a deep love for our university, I am eager to share my enthusiasm with prospective students and their families.

As a highly involved student leader, I have extensive knowledge of ABC’s academic programs, extracurricular activities, campus resources, and student life. I am always eager to share my experiences and insights to help prospective students envision themselves thriving at our university. My strong public speaking skills, friendly demeanor, and passion for ABC make me a natural fit for the Tour Guide role.

Additionally, I bring relevant experience from my customer service role at the campus bookstore. In this position, I greet customers, answer questions, make product recommendations, and maintain a positive attitude. My communication skills, adaptability, and commitment to providing excellent service will translate well to guiding tours and representing ABC University.

I am excited by the opportunity to introduce future students to all that ABC has to offer. I will leverage my campus knowledge, interpersonal skills, and Panther Pride to provide informative, engaging tours that will make a lasting positive impression.

Thank you for considering my application. I have attached my resume for your review. I look forward to the chance to discuss my qualifications and enthusiasm for promoting ABC University.

Subject: Application for Student Life Assistant Work Study Position

I am writing to apply for the Student Life Assistant work-study position at XYZ University. As a sophomore highly involved in campus activities, I am passionate about enhancing the student experience and eager to contribute my skills to the Office of Student Life.

As a student leader in multiple organizations, including the Campus Activities Board and Residence Hall Association, I have firsthand experience planning and executing a variety of events from movie nights to volunteer projects to cultural celebrations. I am organized, and creative, and thrive in collaborative environments. I am confident my event planning skills will enable me to provide valuable support for Student Life initiatives.

Additionally, I bring strong communication, problem-solving, and customer service abilities from my retail job. I am adept at multi-tasking, resolving issues, and providing friendly, efficient service in fast-paced environments. I am confident I can apply these same strengths to promoting Student Life resources and supporting office operations.

I am excited by the prospect of working behind the scenes to create meaningful student development opportunities. I am committed to fostering an inclusive, engaged campus community where every student can find their place.

Thank you for considering my application. I have attached my resume for your review. I would appreciate the opportunity to discuss how I can contribute to Student Life’s mission of enriching the student experience at XYZ University.

Subject: Application for Career Center Assistant Work Study Position

I am excited to apply for the Career Center Assistant work-study position at ABC University. As a junior Human Resources major with a passion for professional development, I am eager to apply my skills while supporting the Center’s important work of preparing students for career success.

Through my HR coursework, I have gained knowledge of job search strategies, resume and cover letter writing, interviewing techniques, and career pathing. I am eager to share these insights with fellow students to help them position themselves for employment. My strong communication, active listening, and interpersonal skills will enable me to effectively assist students in identifying and pursuing their professional goals.

Additionally, I have honed my organizational and project management skills through my HR internship, where I coordinated the employee onboarding program and maintained personnel files. I am detail-oriented, efficient, and committed to providing quality support. I am confident I can apply these same strengths to assisting with Career Center workshops, resources, and administrative tasks.

I am impressed by the Career Center’s wide array of offerings to equip students with the tools to thrive in their careers. I would welcome the opportunity to help expand the Center’s reach and impact to empower more students to achieve professional fulfillment.

Thank you for considering my application. I have attached my resume for your review. I look forward to discussing my qualifications and enthusiasm for the Career Assistant role in more detail.

Subject: Application for Athletic Department Office Assistant Work Study Position

I am thrilled to apply for the Athletic Department Office Assistant work-study position at XYZ University. As a student-athlete on the women’s soccer team with strong administrative skills, I am excited to support the department’s operations while developing professionally in a sports setting.

As a member of the soccer team, I have developed valuable skills in time management, teamwork, and performing under pressure. I pride myself on my strong work ethic, coachability, and commitment to excellence both on and off the field. I am confident I can bring this same driven, team-oriented approach to the Office Assistant role.

Additionally, I have administrative experience from my part-time job at a local law firm, where I manage files, draft correspondence, and provide customer service. My strong organizational, communication, and problem-solving skills will enable me to effectively assist with department recordkeeping, event planning, and special projects. I am proficient in Microsoft Office and quick to learn new programs and processes.

I am passionate about the transformative power of college athletics and XYZ’s commitment to student-athlete success. I would be thrilled for the opportunity to contribute to the department’s mission of providing a top-notch athletic and academic experience.

Thank you for considering my application. I have attached my resume for your review. I look forward to discussing how I can apply my skills and athletics background to add value to the XYZ Athletics Department.

Subject: Application for Campus Recreation Center Guest Services Work Study Position

I am writing to apply for the Guest Services work-study position at the ABC University Campus Recreation Center. As a fitness enthusiast and sophomore Kinesiology major, I am excited to combine my passion for wellness with my customer service skills to enhance the Rec Center experience for patrons.

As a frequent user of the Rec Center myself, I have a firsthand appreciation for the important role the facility plays in supporting student health and campus life. My outgoing personality, attention to detail, and commitment to excellence in all that I do make me a great fit to welcome and assist patrons.

Additionally, my previous experience as a front desk attendant at a physical therapy clinic has honed my customer service, multi-tasking, and problem-solving abilities. I am adept at managing busy phone lines, scheduling appointments, collecting payments, and maintaining a clean, organized front office. I am confident in my ability to apply these same skills to supporting Rec Center operations and providing top-notch service.

I am energized by the opportunity to help create a positive, inclusive environment that encourages the campus community to engage in recreation and wellness. I will bring enthusiasm, professionalism, and dedication to ensuring all patrons have an excellent Rec Center experience.

Thank you for considering my application. I have attached my resume for your review. I would welcome the chance to further discuss my qualifications and passion for promoting healthy lifestyles at ABC University.

Subject: Application for Admissions Ambassador Work Study Position

I am excited to apply for the Admissions Ambassador work-study position at XYZ University. As a junior Communications major who loves sharing my XYZ experience, I am eager to apply my interpersonal skills to help prospective students discover all our university has to offer.

As a student heavily involved in residential life, Greek life, and community service through XYZ’s volunteer center, I have a deep appreciation for the diverse opportunities for growth and connection available here. My strong public speaking skills, ability to connect with diverse individuals, and passion for XYZ make me a compelling ambassador to communicate the university experience to prospective students and families.

Additionally, I bring relevant experience in student outreach from my internship in the Diversity and Inclusion Office, where I helped coordinate multicultural recruitment events and served on student panels. I am skilled at presenting information, facilitating discussions, and addressing questions. I am confident I can bring this same engaging approach to delivering admissions programming that informs and excites prospective students.

I look forward to the opportunity to share my love for XYZ and help future students envision how they can thrive here. I will bring positivity, professionalism, and strong storytelling to showcase the unparalleled XYZ experience.

Thank you for considering my application. I have attached my resume for your review. I would appreciate the chance to further discuss my qualifications and enthusiasm for the Admissions Ambassador role.

Subject: Application for Residence Life Desk Assistant Work Study Position

I am writing to apply for the Residence Life Desk Assistant work-study position at ABC University. As a sophomore Resident Advisor (RA) passionate about fostering strong, supportive living-learning communities, I am excited to contribute my skills and experience to the Residence Life team.

As an RA, I have gained valuable experience in community building, conflict resolution, crisis response, and connecting residents to campus resources. My communication, problem-solving, and interpersonal skills enable me to effectively respond to student concerns and create a welcoming environment. I am confident I can apply these same resident-centered skills to desk operations.

Additionally, I have administrative experience from my previous role as an office assistant, where I greeted visitors, answered phones, organized files, and managed schedules. My strong organizational abilities, attention to detail, and commitment to providing efficient, friendly service will translate well to supporting front desk operations and maintaining accurate records.

I am passionate about Residence Life’s mission of promoting student success and belonging through exceptional residential experiences. I am excited by the opportunity to contribute to this goal by providing top-notch customer service and support to residents.

Thank you for considering my application. I have attached my resume for your review. I look forward to discussing my qualifications and passion for serving residential students in further detail.

There you have it – 15 sample cover letters to help you land your ideal work-study position.

Remember, these are just a starting point. Use them as models and inspiration, but be sure to customize your letter to highlight your unique skills, experiences, and enthusiasm for the specific role and organization.

With a compelling, tailored cover letter, you’ll be well on your way to securing a work-study position that will provide valuable professional experience, help pay for school, and set you up for future career success.

Best of luck in your work-study job search!

AHIP Comment Letter on Interchangeable Biosimilar Applications

Comment Letter

AHIP submitted comments to FDA Commissioner Robert M. Califf, M.D., regarding interchangeable biosimilar applications.

Document Info

Published on Aug 20, 2024

Download and read the full Resource.

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Medical Devices
Device Advice: Comprehensive Regulatory Assistance
How to Study and Market Your Device
Premarket Submissions: Selecting and Preparing the Correct Submission
Investigational Device Exemption (IDE)

IDE Application

On this page:, required elements, suggested content for original ide application cover letter, suggested format for ide submissions, common problems with original ide applications, suggested original ide application administrative checklist, address for ide applications, ide modifications.

A sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.

The following information must be included in an IDE application for a significant risk device investigation. A sponsor cannot begin a significant risk device investigation until FDA and IRB approval are granted. A valid eCopy is typically required and the application must include the following in the order provided (§ 812.20):

Name and address of sponsor
a bibliography of all publications, whether adverse or supportive, that are relevant to an evaluation of the safety and effectiveness of the device
copies of all published and unpublished adverse information
copies of other significant publications if requested by an IRB or FDA
a summary of all other unpublished information (whether adverse or supportive) that is relevant to an evaluation of the safety and effectiveness of the device
if nonclinical laboratory data are provided, a statement that such studies have been conducted in compliance with the Good Laboratory Practice (GLP) regulations in 21 CFR Part 58. If the study was not conducted in compliance with the GLP regulations, include a brief statement of the reason for noncompliance.

Investigational plan (§812.25)

The investigational plan shall include the following items in the following order:

purpose (the name and intended use of the device and the objectives and duration of the investigation)
protocol (a written protocol describing the methodology to be used and an analysis of the protocol demonstrating its scientific soundness)
risk analysis (a description and analysis of all increased risks to the research subjects and how these risks will be minimized; a justification for the investigation; and a description of the patient population including the number, age, sex, and condition)
description of this device (a description of each important component, ingredient, property, and principle of operation of the device and any anticipated changes in the device during the investigation)
monitoring procedures (the sponsor's written procedures for monitoring the investigation and the name and address of each monitor.
additional records and reports (a description of any records or reports of the investigation other than those required in Subpart G of the IDE regulations).
A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device
An example of the agreement to be signed by the investigators and a list of the names and addresses of all investigators. Information that must be included in the written agreement are found in § 812.43
Certification that all investigators have signed the agreement, that the list of investigators includes all investigators participating in the study, and that new investigators will sign the agreement before being added to the study
A list of the names, addresses, and chairpersons of all IRBs that have or will be asked to review the investigation and a certification of IRB action concerning the investigation (when available)
The name and address of any institution (other than those above) where a part of the investigation may be conducted
The amount, if any, charged for the device and an explanation of why sale does not constitute commercialization
Please note that an environmental assessment as required under 21 CFR 25.40 or a claim for categorical exclusion under 21 CFR 25.30 or 25.34 is no longer required. [§25.34(g)]
Copies of all labeling for the device
Copies of all informed consent forms and all related information materials to be provided to subjects as required by 21 CFR 50, Protection of Human Subjects
Any other relevant information that FDA requests for review of the IDE application. Information previously submitted to FDA in accordance with Part 812 may be incorporated by reference.

It is recommended that the cover letter include the following information in the order provided to assist in the administrative processing of the application.

Statement that the information provided is an original IDE submission.
Device Name
Intended Use
Contact Person
Telephone Number
Email address - all correspondence from FDA will be sent via email
Correspondent Information: If the organization submitting the application is not the sponsor, such as a consultant or a lawyer, include contact information for the correspondent organization or individual.
Q-Submissions/Pre-Submissions: Describe any discussions with the FDA about this device. If a Pre-Submission (Pre-Sub) was submitted, state the Pre-Sub number and provide a copy of the written feedback provided by the FDA. If a Pre-Sub meeting occurred, provide the name of the FDA contact person and a copy of the meeting minutes.
Study Risk Determination (SRD) Q-Submission: If a SRD Q-Submission (Q-Sub) was submitted, provide the Q-Sub number and a copy of the determination letter provided by the FDA.
Waiver Requests: Identify any requests for waivers and include a justification for the waiver.
Referenced Files: Identify any files that are referenced in the IDE application, such as Premarket Approval, Premarket Notification 510(k), IDE, or device master files. If files were not submitted by the sponsor, include a letter from the owner of the files that grants FDA permission to reference the files in its review of the current application.

In order to facilitate FDA's handling of IDE applications, the following recommendations are offered:

Clearly and prominently identify submission as original IDE application or, for additional submissions to an IDE application, clearly identify the FDA assigned document number (e.g., G960000) and the reason for the submission (e.g., amendment, supplement, or report) and the type of submission (e.g., Response to FDA Approval with Conditions letter; Change to Protocol, Annual Report, etc.).
Include a valid eCopy per the guidance document titled " eCopy Program for Medical Device Submissions ."
Do not combine IDEs, PMAs and 510(k)s together; they must be separate submissions.
Unless the IDE sponsor has provided authorization in writing for another person to submit information on the sponsor's behalf, only the IDE sponsor may amend, supplement, or submit reports to the IDE.

The sponsor should assure that the device, all preclinical testing, and the investigational plan are described and provide adequate justification for the initiation of the clinical trial. Submitters should avoid submitting the IDE application prematurely. There are three common areas that are frequently deficient in IDE applications.

Inadequate report of prior investigations
Inadequate investigational plan
Inadequate/incomplete design and manufacture

Common deficiencies with report of prior investigations

A report of prior investigations must include reports of all prior clinical, animal, and laboratory testing of the device. It should be comprehensive and adequate to justify the proposed investigation. If a particular type of prior investigation was not conducted (e.g., no animal testing or no clinical study), the report of prior investigations should provide a rationale.

inadequate description of methods
inadequate or no summary or conclusion
conclusions not supported by data
no rationale for animal selection
no scientific justification for the number of animals selected
inappropriate duration or follow-up
failure to address compliance with Good Laboratory Practices for Nonclinical Studies, 21 CFR 58
incomplete searches
copies of relevant publications not included
omission of adverse information
failure to identify relevant parts or information and to summarize

Common deficiencies with investigational plan

failure to clearly develop or define study objectives
inadequate description of the protocol
failure to identify all risks
investigational plan includes elements that would expose study subjects to unacceptable probable risks
failure to develop proper monitoring procedures
inadequate informed consent documents
Common deficiencies with design and manufacturing
Design/engineering drawing of device
Rationale for device design
Device and performance specifications
Description of materials (including biocompatibility information)
Description of function - how does device and/or components/subsystems work together to achieve desired function
Validation testing for subsystems and main system
Manufacturing: Inadequate or missing description of the controls used to ensure that the devices are produced consistently and as designed.

Following is a suggested checklist that submitters may use to ensure that their original IDE application is administratively complete. The first section is a screening to determine whether an IDE application is required to be submitted to FDA. The next section is the information suggested to be included in the cover letter or cover page of the IDE application. Inclusion of this information should help speed FDA's administrative processing of the application. The last section is a checklist to ensure that all the information required by regulation is addressed in the application.

Screening Information - Is an IDE application to FDA necessary?

Is the investigation within the categories exempt from the IDE regulation under §812.2(c)? (If yes, stop. IDE application is not required. IRB clearance and informed consent is recommended; please check institution's policies.)	Yes/No
Is this a nonsignificant risk device investigation? (If yes, stop. Submission to and approval from FDA is not required for nonsignificant risk devices. Follow abbreviated requirements (§812.2(b)) including IRB approval and informed consent.)	Yes/No
If the answer to both of these questions is no, an IDE application must be submitted to FDA and approval must be obtained from both FDA and the IRB before the study may begin

Checklist for Cover Letter


Statement that submission is an original IDE application.	Yes/No
Device Information:	Yes/No
Sponsor – (must be located in United States) [§812.18(a)]:	Yes/No
Manufacturer Information	Yes/No
Correspondent Information (Note: IDE application will not be approved without a U.S. sponsor) [§812.18(a)]	Yes/No
If applicable, provide the following information:	Yes/No

Checklist for an IDE Application


Format for submission: Table of contents (recommended) Paginated pages (recommended)	Yes/No
Report of Prior Investigations (§ 812.27): Are the following items provided and are they comprehensive and adequate to justify the proposed investigation?
	Yes/No
	Yes/No
	Yes/No
	Yes/No
If any studies were not conducted in compliance with the GLP regulation, a brief statement of the reason for the noncompliance must be provided. Failure or inability to comply with this requirement does not justify failure to provide information on a relevant nonclinical test study.	Yes/No
If any item is not provided, a justification for its omission must be provided.
Investigational Plan (§ 812.25): Are the following items included, preferably in the following order:
Purpose: Are the following clearly defined?	Yes/No
Protocol: Are the following items provided and adequate?	Yes/No
Risk Analysis: Are the following items provided and adequate to determine that the benefit and knowledge to be gained from the investigation outweigh the risks to the subjects?	Yes/No
Description of the Device: Are the following items provided and adequate?	Yes/No
Monitoring Procedures: Are the following items present?	Yes/No
Manufacturing Information: [812.20(b)(3)] Is adequate manufacturing information provided to allow a judgement about the quality control of the device (e.g., that the device will meet the intended specifications) based on the description of methods, facilities and controls used for: a. manufacturing b. processing c. packing d. storage e. installation	Yes/No
Investigator Information: [812.20(b)(4)] Are the following items included?
Example of investigator agreement [ ] which should include:	Yes/No
Certification that all participating investigators have signed the agreement and that no investigator will be added until the agreement is signed. [812.20(b)(5)]	Yes/No
Name and address of investigators who have signed the agreement.	Yes/No
IRB Information: Are the following items included?
Name, address, and chairperson of each IRB	Yes/No
Certification of the action taken by each IRB, (i.e., approval letter)	Yes/No
Names and addresses of any institutions (other than those identified above) where a part of the investigation may be conducted	Yes/No
Sales Information: [812.7(b)] Is the following information provided?
Is the device to be sold?	Yes/No
If yes, is the amount to be charged provided?	Yes/No
Explanation of why sale does not constitute commercialization	Yes/No
§ 812.7(b) prohibits the commercialization of an investigational device by charging subjects or investigators for a device a price larger than necessary to recover costs of manufacture, research, development, and handling.
Environmental Impact Assessment: [§812.20(b)(9)] An environmental impact assessment or a claim for categorical exclusion is no longer required. [§25.34(g)]
Labeling: [§812.5] Are copies of all labeling for the device provided and include the following?
Does the labeling contain the statement "CAUTION-Investigational Device. Limited by Federal (or United States) Law to Investigational Use." [§ 812.5(a))]	Yes/No
Does the labeling contain adequate information for the purposes of the investigation, in accordance with § 812.5(a), including the name and place of business of the manufacturer, packer, or distributor, the quantity of contents, and a description of all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions? If any item is not addressed, a justification for its omission must be provided.	Yes/No
Note: The device may not be promoted as safe and effective for the use for which it is being investigated. [§812.7(d)]
Informed Consent Materials: [21 CFR 50, 812.25(g)]
Are all forms and informational materials to be presented to the subject included?	Yes/No
Does the informed consent form seek consent from the subject or a legally authorized representative, when appropriate (e.g., when the subject is a minor)?	Yes/No
Does the informed consent form contain the basic required elements? ( ) Required Elements:	Yes/No
Additional Elements Required When Justified:	Yes/No/NA
The informed consent form may not contain exculpatory language [21 CFR Part 50.20]
Elements: Informed Consent and Clinical Trials.gov	Included
Title VIII of the Food and Drug Administration Amendment Act of 2007 (FDAAA) expanded the ClinicalTrials.gov database to include mandatory registration and reporting of results for applicable clinical trials of human drugs and devices. You should review 42 U.S.C. 282(j) to determine whether the requirements of FDAAA apply to this application/submission. Additional information on registering your clinical trials is available at the Protocol Registration System (PRS) Information Site at . If this is an “applicable clinical trial” ( ), does the informed consent form contain the following statement?: “A description of this clinical trial will be available on , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”	Yes/No/NA
Other Information: Provide additional information supportive of the investigation and any information FDA has identified (through previous contact with the agency or through guidance documents) as required. If any item is not provided, a justification for its omission must be provided.

For original IDE applications and most IDE supplements, amendments and reports, a valid eCopy is required. Please refer to our eCopy Guidance Document regarding types of IDE submissions that are exempt from submitting an eCopy. There are no IDE application forms. For most devices, you must mail the Company Cover Letter and valid eCopy to CDRH’s or CBER’s Document Control Center (DCC). The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage .

All correspondence relating to an IDE should also be sent to these addresses with a valid eCopy and reference the IDE number. The Company Cover Letter of each submission should identify the submission type, for example, "Original IDE Application," "IDE Supplement," "IDE Report," etc.

For devices regulated by the Center for Biologics Evaluation and Research (CBER) please contact them for further assistance at either 1-800-835-4709 or [email protected]

Changes in investigational plan that require prior approval (§ 812.35)

A sponsor must obtain approval of a supplemental application and IRB approval, when appropriate under conditions described in §56.110 and §56.111, prior to implementing a change to an investigational plan except in situations described below. If a sponsor intends to conduct an investigation that involves an exception to informed consent under §50.24 ( see Informed Consent ), the sponsor must submit a separate investigational device exemption (IDE) application [§812.20(a)].

The IDE supplement should be identified as an "IDE Supplement" with the IDE number on the Company Cover Letter and submitted with a valid eCopy .

Changes that do not require prior FDA approval.

The sponsor of an IDE may modify the device and/or clinical protocol without approval of a new IDE application or IDE supplement if the modifications meet certain criteria. The notice must be provided to FDA within 5 working days of making the change.

Emergency Use FDA approval of a supplement does not apply in the case of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. However, such deviation must be reported to FDA within 5-working days after the sponsor learns of it [§812.150(a)(4)].

Criteria: An FDA approved IDE supplement is not required for developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or basic principles of operation and that are made in response to information gathered during the course of an investigation. This determination is made by the sponsor and must be based on credible information. Credible information to support developmental changes in the device (including manufacturing changes) includes data generated under the design control procedures of §820.30, preclinical/animal testing, peer reviewed published literature, or other reliable information such as clinical information gathered during a trial or marketing. The sponsor must provide notice to FDA within 5-working days of making these changes.

Generic types of device and manufacturing changes include changes to the control mechanism, principle of operation, energy type, environmental specifications, performance specifications, ergonomics of patient-user interface, dimensional specifications, software or firmware, packaging or expiration dating, sterilization, and the manufacturing process (including the manufacturing site). Any specific change within a particular type may or may not be appropriate under the 5-day notice provision because changes in each of these categories could range from minor to significant depending upon the particular device, the type of modification, and the extent of the modification. The impact of the change would still need to be determined by information generated by design controls or other appropriate means to assess the significance of the change to the device design or manufacturing process and the appropriateness of a 5-day notice submission.

Please note that all developmental changes need to be reported to the IRB in the sponsor’s annual report. In addition, the changes may be subject to IRB review procedures under 21 CFR 56.110.

All changes to the basic principles of operation of a device are considered to be significant changes that should be submitted in an IDE supplement.

5-day Notice: The sponsor must submit a notice of the change to the IDE no later than 5-working days after making the change. Changes to devices are deemed to occur on the date the device, manufactured incorporating the design or manufacturing change, is distributed to the investigator(s). These notices must be identified as a "notice of IDE change.''

For a developmental or manufacturing change to the device, the notice must include a summary of the relevant information gathered during the course of the investigation upon which the change was based; a description of the change to the device or manufacturing process (cross-referenced to the appropriate sections of the original device description or manufacturing process); and, if design controls were used to assess the change, a statement that no new risks were identified by appropriate risk analysis and that the verification and validation testing, as appropriate, demonstrated that the design outputs met the design input requirements. If another method of assessment was used, the notice must include a summary of the information which served as the credible information supporting the change. FDA will only notify the sponsor if questions arise or additional information is needed.

The validity of the data or information in the approved protocol, or the patient risk to benefit relationship relied upon to approve the protocol
The scientific soundness of the investigational plan
The rights, safety, or welfare of the human subjects involved in the investigation.
This determination is made by the sponsor and must be based on credible information. Credible information to support changes to clinical protocols is defined as the sponsor's documentation supporting the conclusion that a change does not have a significant impact on the study design or planned statistical analysis, and that the change does not affect the rights, safety, or welfare of the subjects. Documentation must include information such as peer reviewed published literature, the recommendation of the clinical investigator(s), and/or the data gathered during the clinical trial or marketing. The sponsor must provide notice to FDA within 5 working days of making these changes.

Examples of these types of changes may include the following changes:

Modification of inclusion/exclusion criteria to better define the target patient population
Increasing the frequency at which data or information is gathered
Inclusion of additional patient observations or measurements
Modifying the secondary endpoints (Secondary endpoints usually support a secondary labeling claim that the sponsor wants to make for the device and are not used to determine the safety or effectiveness of the device.)

5-day Notice

The sponsor must submit a notice of the change to the IDE no later than 5 working days after making the change. Changes to a clinical protocol are deemed to occur when a clinical investigator is notified by the sponsor that the change should be implemented in the protocol or, for sponsor-investigator studies, when a sponsor-investigator incorporates the change in the protocol. These notices must be identified as a "notice of IDE change."

For a protocol change, the notice must include a description of the change (cross-referenced to the appropriate sections of the original protocol); an assessment supporting the conclusion that the change does not have a significant impact on the study design or planned statistical analysis; and a summary of the information that served as the credible information supporting the sponsor's determination that the change does not affect the rights, safety, or welfare of the subjects. FDA will only notify the sponsor if questions arise or additional information is needed.

Changes to be submitted in the annual report

Minor changes in the following areas:

the purpose of the study
risk analysis
monitoring procedures
informed consent materials
IRB information

May be reported in the annual progress report for the IDE, if the changes do not affect:

the validity of the data or information resulting from the completion of the approved protocol or the relationship of likely patient risk to benefit relied upon to approve the protocol;
the scientific soundness of the investigational plan; or
the rights, safety, or welfare of the human subjects involved in the investigation 21 CFR 812.150(b)(5)]

If the changes do affect the above criteria, then prior FDA approval must be obtained.

IDE supplements for new facilities(s)

If an initial IDE application does not contain a certification of IRB approval for each investigational site, FDA may approve the investigational sites without IRB approval. The sponsor is required to submit the certification in an IDE supplement when IRB approval is obtained. If the site is already approved and the supplement is just the certification of IRB approval, FDA usually does not provide a written response to the certification beyond acknowledging receipt since the site has previously been approved by FDA.

In instances where the sponsor has determined the number of investigational sites for the study, but has not identified all the sites, the FDA may grant a waiver at the time of IDE approval. This waiver will allow the sponsor to enroll the sites, obtain IRB approvals, and then submit all the certifications of IRB approval to FDA as part of the IDE annual progress report instead of requesting each site as it is identified.

Once the IDE is approved, the sponsor may submit an IDE supplement to request approval of additional clinical study sites. FDA will respond in writing to the supplement approving or denying the request. The sponsor is required to submit:

Identification of the investigational site
certification of IRB approval for a new site may be submitted once IRB approval is obtained (or, if a waiver has been granted, certification(s) of IRB approval may be provided in the IDE annual progress report)
Information updating the initial IDE application (if the investigation is changed)
A description of any modifications required by the IRB as conditions of approval

References:

21 CFR 812.20
21 CFR 812.25
21 CFR 812.27
21 CFR 812.35
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff

Cover letter examples

Product Manager

Umut Yilmaz, a seasoned Product Manager, opted for the Cornell template to highlight his extensive experience in product management. He adeptly blends strategic planning, market research, and cross-functional collaboration to drive product success.

"Throughout my career, I have successfully led cross-functional teams in the development and launch of products across various industries. My ability to translate complex ideas into actionable product strategies has consistently resulted in products that not only meet market demands but also exceed business objectives."

Table of contents

How to Write a Product Manager Cover Letter

In the rapidly changing tech and AI landscape, product managers (PMs) are essential in transforming innovative ideas into successful products. They oversee the journey from concept to launch, ensuring that products meet market needs and engage users effectively. Their role combines strategic thinking with practical execution, requiring both creative insight and technical expertise.

So, which type of product manager are you? The roles include, but are not limited to:

Associate Product Manager

Technical Product Manager

Digital Product Manager

Growth Product Manager

Data Product Manager

Product Marketing Manager

AI Product Manager

Product Lead

Principal Product Manager

Head or VP of Product

Chief Product Officer.

Looking to land a job for one of the above roles?

If you’re seeking to enter or advance within product management , a good cover letter is key to landing more job interviews . A PM cover letter should convey your unique blend of skills, experiences, and passion for finding solutions while aligning with the specific needs and goals of the company you're targeting.

In this guide, we will explore: How to write a product manager cover letter. What to include in a product manager cover letter. Strategies for writing a product manager cover letter if you have no experience

Product manager cover letter example

To make your job application stand out even more, ensure consistency by using the same templates or design. Interested in a CV? Check out the matching product CV example.

What to include in a product manager cover letter?

A strong product management cover letter, much like a good CV , should begin with your contact information at the top, formatted in a professional business letter style. Be sure to include your name, location, phone number, and email address.

sections of a product manager cover letter

1. Intro: How to start a product manager cover letter

The introduction of your product manager cover letter sets the tone for your application and captures the reader's attention. It should be personalised, clearly stating the position you're applying for and briefly outlining why you're a strong fit for the role.

AI product manager cover letter example

I am excited to apply for the AI Product Manager position at Adobe, as advertised. With a solid background in both product management and artificial intelligence, including my recent work leading an AI driven project that increased user engagement by 30%, I am confident in my ability to contribute to Adobes AI innovative initiatives. My passion for harnessing AI to solve complex problems aligns perfectly with your companys mission to drive technological advancements.

Entry-level product manager cover letter example

I am writing to express my enthusiasm for the Entry-Level Product Manager role at Luna. As a recent graduate with a degree in Business Administration and a hands-on internship experience managing product development cycles, I am eager to bring my strong analytical skills and fresh perspective to your team. My recent project, which involved coordinating cross-functional teams to launch a new app feature, has prepared me to make meaningful contributions to your company.

Technical product manager cover letter example

I am thrilled to apply for the Technical Product Manager position at Adobe. With a robust background in product management and technical expertise, I recently spearheaded the development of a cloud-based platform that slashed system downtime by 40%, significantly enhancing user experience. I am confident in my ability to drive Adobes pioneering projects forward. My deep passion for utilising technology to solve complex challenges aligns perfectly with mission to lead in innovation and set new industry standards.

For additional examples, refer to how to start a cover letter or look at our extensive list of cover letter examples.

2. Body: How to write the body of a product manager cover letter

In the main body of your cover letter for a product manager, focus on detailing your qualifications and experiences, showing how they meet the employer's needs. After highlighting relevant skills, take it a step further by providing concrete examples to illustrate those skills in action. Whether you have a decade of experience or are just starting out, it's important to showcase relevant accomplishments, big or small, and explain how your unique expertise can add value to the team.

how to write a product manager cover letter

In my previous role at Google, I led a cross-functional team in developing an AI-driven recommendation engine that improved customer retention by 25%. My hands-on experience with machine learning algorithms and data analysis allowed me to bridge the gap between technical teams and business stakeholders effectively. I also implemented AI tools that streamlined product development processes, resulting in a 15% reduction in time-to-market for new features.

During my internship at Creative Sparks, I assisted in managing the lifecycle of a new app feature from concept through launch. My responsibilities included gathering user feedback, defining feature requirements, and coordinating with development teams. I played a key role in conducting market research and analysing user data, which informed product decisions and led to a 10% increase in user satisfaction. My academic background in Business Administration, combined with my hands-on experience, has equipped me with the foundational skills needed to excel in this entry-level product manager role. I am eager to apply my knowledge and contribute to Luna’s product management team

There is no one-size-fits-all cover letter strategy. For more tips, check out our article on cover letter structure.

3. Conclusion: How to end a product management cover letter

The conclusion of your product manager cover letter should leave a strong impression by summarising your enthusiasm for the role, reiterating your fit for the position, and outlining the next steps. It’s your final chance to encourage the hiring manager to take action.

how to end a product manager cover letter

With a genuine dedication to driving innovative product solutions and enhancing user experiences, I am thrilled at the prospect of joining the dynamic team at Luna as a Product Manager. I am excited to leverage my skills and experience to contribute to your product development efforts and support the company's mission to deliver outstanding solutions that resonate with users. Thank you for considering my application. I am enthusiastic about the opportunity to bring my strategic vision and hands-on expertise to Luna and am eager to further discuss how I can make a meaningful impact on your product initiatives. I look forward to the possibility of discussing this exciting opportunity with you in an interview. Kind Regards, Sean Williams

How to write a product manager cover letter example (no experience)

Writing a cover letter can already be a challenge in itself, especially when you're applying for a role in product management with no experience. However, with the right approach, you can highlight your transferable skills , passion for the industry, and willingness to learn, making you a strong candidate despite your lack of direct experience.

product manger cover letter no experience

Dear Hiring Manager, I am writing to express my interest in the Junior Product Manager position at Adobe, as advertised. As a recent graduate with a degree in Business Management, I am eager to begin my career in product management, leveraging my strong analytical skills, collaborative nature, and passion for innovation. During my time at the University of London, I completed several relevant courses such as Product Development, Market Research, and Data Analytics. These courses provided me with a solid foundation in understanding customer needs, market trends, and the product lifecycle, which I believe are highly transferable to product management. My academic projects, particularly a capstone project where I led a team to design and develop a mobile app prototype, allowed me to experience the product development process firsthand—from ideation to user feedback and iteration. This hands-on experience enhanced my ability to analyse user requirements, prioritise features, and work effectively within a team. Although I am new to the field, I am highly motivated and a fast learner, ready to take on the challenges of product management. I am particularly drawn to Adobe because of its innovative products and commitment to pushing the boundaries of creativity and technology. I am eager to bring my fresh perspective and dedication to your team. Thank you for considering my application. I look forward to the possibility of discussing how I can contribute to Adobe. Sincerely, Sarah Jones

This example highlights how a recent graduate can focus on their transferable skills and enthusiasm for the role, making a strong case for their candidacy despite a lack of direct experience. For more examples, refer to how to write a cover letter with no experience . For additional examples, refer to how to end a cover letter.

Key takeaways

Tailor to the company and address a specific person.

Use formal language and clear structure.

State the position and express enthusiasm.

Highlight relevant skills and achievements.

Connect your experience with the company's goals.

Showcase technical proficiency.

Mention teamwork and leadership.

Discuss career goals and fit with the company.

Reiterate interest, request an interview, and thank the reader.

Check for errors and keep it concise.

Next steps?

If you're unsure about the layout or content of your product manager cover letter, browse our extensive collection of cover letter templates and CV examples for inspiration. Alternatively, you can seek help from a professional through our CV Writing Service , which also offers LinkedIn profile optimisation.

Create your product manager cover letter

How do i write a cover letter for an associate product manager.

Tailor your cover letter to the company and the associate product manager role by emphasising your relevant skills and any prior experience. Highlight your eagerness to learn and grow within the field, providing examples of teamwork and problem-solving abilities. Show how your background aligns with the company’s mission and goals to demonstrate your fit for the position.

What is the best letter template for a product management cover letter?

An effective template includes an introduction stating the position and expressing enthusiasm, a body section that highlights your key achievements and skills while aligning them with the company's needs, and a conclusion that reiterates your interest, requests an interview, and thanks the reader. This structure ensures clarity and relevance. For additional tips, check out the ideal cover letter length and the best font for a cover letter.

How do I write a cover letter for a product marketing manager?

Focus on showcasing your marketing skills and experience with product management. Highlight specific achievements in product launches, market analysis, and campaign management. Make sure to align your experience with the company’s marketing strategy and objectives, demonstrating how you can contribute to their success.

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COMMENTS

Information to include with Cover Letter
• The cover letter should clearly state any significant changes to the application (i.e., formulation change, new strength amendment, etc.) in the heading and body of the cover letter
IND Applications for Clinical Treatment: Contents and Format
The Cover Letter is used for triaging and routing of an IND application within FDA and is expected to include the following: Submission Identifier: "Expanded Access Submission". Brief ...
IND Applications for Clinical Investigations: Regulatory and
The Cover Letter is typically addressed to the Director of the Review Division in the Office of New Drugs and signed by the sponsor of the IND application. Form 1571 (PDF - 830KB) This form ...
Initial IND Application
The cover letter is the first piece of information that the FDA sees upon receipt of an Initial IND submission. It expresses the intent of the investigator to request FDA review of the enclosed information, and briefly describes the proposed research. ... Title the cover letter: "Initial Investigational New Drug Application" Brief explanation ...
ReGARDD
The cover letter is the first piece of information that the FDA sees upon receipt of an Initial IND submission. It expresses the intent of the sponsor-investigator to request FDA review of the enclosed information, and briefly describes the proposed research. ... Title the cover letter: "Initial Investigational New Drug Application" Brief ...
PDF CLINICAL INVESTIGATOR How do I put together an IND application?
Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. Subject. A human who participates in an investigation either as a recipient of the investigational drug or as a control. A subject may be a healthy human or a patient with a disease.
Federal Register :: Cover Letter Attachments for Controlled
The collections of information for Form FDA 356h (NDA and ANDA cover letter) have been approved under OMB control number 0910-0338. Applicants submit to FDA controlled correspondence along with cover letters related to generic drug development and FDA approval. Such submissions have been approved under OMB control number 0910-0797.
PDF Cover Letter Attachments for Controlled Correspondences and ANDA
60 not required to submit an attachment with their cover letter; however, the optional checklist 61 attachment can be a useful guide to help applicants prepare their cover letters. Completing a 62 relevant checklist and attaching it to the cover letter submission is helpful to FDA in the triage of 63 applications and management of submissions.
PDF SUBMITTED ELECTRONICALLY
SUBMITTED ELECTRONICALLY. Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061 Rockville, MD 20852. Re: Docket No. FDA-2021-D-0861—Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions; Draft Guidance for ...
PDF IND Application Cover Letter
We are submitting this initial application for a Sponsor-Investigator IND. We propose to evaluate [Drug generic name (Trade Name®)] under this IND for safety and efficacy for the treatment of [disease or condition]. This submission also contains the initial study protocol [Study Number] Protocol v. 1.0] entitled, "[XXX].".
PDF How To Put Together An IND Application
Cover letter. Typically 1 - 2 pages and addressed to Review Division Director. Identifies the submission as an "Initial IND Application". Includes a brief explanation of the intended investigation. Study title and type/phase of trial. IND name and formulation (e.g., tablets, solution, pre-filled syringe, etc.)
FDA Publishes Guidance for industry: Cover Letter Attachments for
These cover letter attachments have been designed as a checklist to reflect common types of information applicants are expected to address in their cover letters. The attachments are intended to serve as a useful guide to help applicants prepare their cover letters and to assist FDA in the triage and management of submissions.
Cover Letter Attachments for Controlled Correspondences and ANDA
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for IndustryJune 2023. This guidance is intended to assist prospective applicants, applicants, and holders of ...
PDF DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
to approved ANDAs submitted to FDA. A cover letter is generally included with controlled correspondence to OGD and submissions to an ANDA file. While a cover letter is not required content for an ANDA, the cover letter is a part of the electronic common technical document (eCTD) hierarchy and is included in Module 1 of an ANDA submission.
IND Templates, Education & Useful Links
IND Submissions. IND Checklist for IND Submission. FDA Form 1571 - IND Application. FDA Form 1572 - IND Investigator Statement. FDA Form 1572 (Box 8) - Protocol Summary Template. FDA Form 3454 - Certification: Financial Interests and Arrangements of Clinical Investigator. FDA Form 3455 - Investigator Financial Interest Disclosure.
PDF FAQs
ion?Identify your first eCTD sequence as a general correspondence submission in the cover letter and FDA. orm. State that the application will be submitted in eCTD format from this date forward and then intentionally code the us-regional.xml as the original applica. ion.When transitioning to eCTD, what should the first eCTD sequence be code.
PDF 510(k) Cover Letter
Natus Medical Incorporated DBA Excel-tech Ltd. (Xltek) Sanjay Mehta Senior Manager Quality and Regulatory Affairs 2568 Bristol Circle Oakville, CA L6H5S1. Re: K152301 Trade/Device Name: Background Pattern Classification (BPcTM) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMA ...
Federal Register :: Cover Letter Attachments for Controlled
The collections of information for Form FDA 356h (NDA and ANDA cover letter) have been approved under OMB control number 0910-0338. Applicants submit to FDA controlled correspondence along with cover letters related to generic drug development and FDA approval.
510k Cover Letter and FDA Form 3514
510k Cover Letter Webinar ($29) 510k Cover Letter Webinar. In this 20 minute webinar you will learn how to prepare a 510k Cover Letter and complete FDA Form 3514-including identification of recognized standards. You will also receive copies of the templates for both documents--updated for 2020. Price: $29.00.
15 Sample Cover Letters for Work Study Position
But before you can land the job, you need to write a compelling cover letter that will make you stand out from the competition. Cover letters are your chance to sell yourself to potential employers, highlighting your relevant skills, experiences, and enthusiasm for the role. ... 15 Sample Cover Letters for Dependent Visa Application; 15 Sample ...
Cover Letter Attachments for Controlled Correspondence and ANDA Submissions
cover letter submission is helpful to FDA in the triage of applications and management of submissions. The cover letter attachment provided in Appendix 1 of this guidance is intended for use with
PDF FDA Cover Letter 22MAR2016
Contact person: Peng Cui, Regulatory Affairs Specialist Email: [email protected] Tel: (978) 659-7966 Fax: (978) 487-4450. Date prepared: March 21, 2016. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
FDA Issues Complete Response Letter For Regeneron's ...
(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) said that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL for the Biologics License Application or BLA for ...
PDF Department of Health and Human Services
ANDAs submitted to FDA. A cover letter is generally included with controlled correspondence to the Office of Generic Drugs and submissions to an ANDA file. While a cover letter is not required content for an ANDA, the cover letter is a part of the electronic common technical document hierarchy and is included in Module 1 of an ANDA submission.
AHIP Comment Letter on Interchangeable Biosimilar Applications
AHIP submitted comments to FDA Commissioner Robert M. Califf, M.D., regarding interchangeable biosimilar applications. Document Info Published on Aug 20, 2024
Regeneron Provides Update on Biologics License Application for
TARRYTOWN, N.Y., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
IDE Application
The next section is the information suggested to be included in the cover letter or cover page of the IDE application. Inclusion of this information should help speed FDA's administrative ...
Product Manager Cover Letter (Guide with Examples)
For additional examples, refer to how to start a cover letter or look at our extensive list of cover letter examples. 2. Body: How to write the body of a product manager cover letter. In the main body of your cover letter for a product manager, focus on detailing your qualifications and experiences, showing how they meet the employer's needs.