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U.S. Department of Health and Human Services

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IND Applications for Clinical Investigations: Regulatory and Administrative Components


The following table includes explanations of various components of an IND application and links to additional information related to application submission.   
 

Cover Letter

(typically 1 page or less)     

The Cover Letter is used for triaging and routing of an IND application within FDA and is expected to include the following:  

  • Submission Identifier: “Initial Investigational New Drug Application”

  • Brief explanation of the intended investigation (type and title of study)

  • Investigational new drug product’s name and proposed formulation

  • Disease or condition under investigation

  • IND manufacturer’s name and contact information (if applicable)

  • Reference to an existing IND application (if applicable) 

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 includes administrative information pertinent to the IND application Instructions for completion (PDF - 151KB)
Form 1572 (PDF -718KB)      This form represents Statement of the Investigator conducting clinical research under the IND application. For frequently asked questions, refer to Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (PDF - 105KB).
Form 3674 (PDF - 3MB)This form represents certification of compliance with requirements of ClinicalTrials.gov Data Bank. Instructions for completion (PDF - 129KB)
Table of Contents  The Table of Contents for IND application is expected to be detailed enough to permit FDA reviewers to locate items in the application quickly and easily. It is helpful if location of information is provided by volume and page.

Introductory Statement and General Investigational Plan

(typically 2-3 pages)
 
This section is intended to place the clinical development plan for the Investigational New Drug into perspective and to help FDA anticipate the needs of the future program. Upon initial submission of an IND application, the detailed developmental plan may not be well established yet and could be contingent on many factors. In this case, the IND application’s sponsor should state this and provide a brief explanation of future plans for clinical development.

Chemistry, Manufacturing, and Control Information 

Refer to Non-Clinical Components.

Pharmacology Toxicology Information 

Refer to Non-Clinical Components.  

Investigator’s Brochure 

Investigators may obtain Investigator’s Brochure (IB) from IND product’s manufacturer. For investigator-initiated IND applications that have a right of reference to an existing manufacturer’s IND application, submission of the IB is not required. IB is updated as the development program progresses and new information becomes available.  IB is expected to contain the following information:

  • Brief description of the drug substance and the formulation, including the structural formula, if known

  • Summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans

  • Summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans

  • Summary of information relating to safety and effectiveness in humans obtained from prior clinical studies

  • Description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug. Adverse Events (AEs) described in the IB help determine whether an AE that occurs during a clinical trial is “expected” and, if so, how it will be reported to FDA. 

For suggested format of Investigator’s Brochure refer to Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance (PDF - 262KB)

Clinical Protocol(s)Refer to Clinical Components.
Summary of Previous Human Experience with the Investigational Drug Refer to Clinical Components.

Additional Information

In certain applications, information on special topics may be needed. Such additional information may include: drug dependence and abuse potential (e.g., for psychotropic IND products), radiation absorption calculations for radioactive drugs, plans for pediatric studies, or any other information pertinent to development of the IND product. If no additional information is relevant, this section may be considered not applicable. 

For information on abuse potential evaluation, see the draft Guidance for Industry: Assessment of Abuse Potential of Drugs (PDF - 175KB)

Other Relevant Information

If requested by FDA, other relevant information pertinent to review of the IND application may need to be submitted.

 

Other FDA’s Public Use Forms can be found on FDA’s Forms & Reports Page.