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).