IND Applications for Clinical Investigations: Regulatory and Administrative Components

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

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.

Introductory Statement and General Investigational Plan

Chemistry, Manufacturing, and Control Information

Pharmacology Toxicology Information

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.

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.

Other Relevant Information

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

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