Summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans Summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans IB is expected to contain the following information:īrief description of the drug substance and the formulation, including the structural formula, if known IB is updated as the development program progresses and new information becomes available. 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. Investigators may obtain Investigator’s Brochure (IB) from IND product’s manufacturer.

In this case, the IND application’s sponsor should state this and provide a brief explanation of future plans for clinical development.Ĭhemistry, Manufacturing, and Control Information Upon initial submission of an IND application, the detailed developmental plan may not be well established yet and could be contingent on many factors. 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. Introductory Statement and General Investigational Plan(typically 2-3 pages) It is helpful if location of information is provided by volume and page. 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. Instructions for completion (PDF - 129KB) This form represents certification of compliance with requirements of Data Bank. For frequently asked questions, refer to Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (PDF - 105KB). This form represents Statement of the Investigator conducting clinical research under the IND application. This form includes administrative information pertinent to the IND application Instructions for completion (PDF - 151KB)

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. Reference to an existing IND application (if applicable) IND manufacturer’s name and contact information (if applicable) Investigational new drug product’s name and proposed formulation Submission Identifier: “Initial Investigational New Drug Application”īrief explanation of the intended investigation (type and title of study) The Cover Letter is used for triaging and routing of an IND application within FDA and is expected to include the following:

Table e6-3.1 polymath program