Compiling the Initial IND Submission

The IND Sponsor-Investigator compiles information for the IND in three broad areas:

Animal Pharmacology and Toxicology Studies: Preclinical data used to assess whether the product is reasonably safe for studies in humans. For studies of marketed drugs in new indications, this section might contain data from animal models supporting the utility of the drug in the new indication.
Manufacturing Information: The composition, stability, and controls used for manufacturing the drug substance and the drug product.

- For marketed drugs, the FDA already has this information on file in the manufacturer’s Drug Master File (DMF). An Investigator-Sponsor can request a Letter of Authorization (LOA) from the manufacturer to refer to the information, although it is not required.
- For legally marketed drugs, the information in the product label might suffice for the manufacturing information.

Clinical Protocols and Investigator Brochures: A detailed clinical study protocol, and Investigator Brochure are required sections of an IND application. The Investigator Brochure is primarily needed for multi-center studies and is a summary of information needed by participating investigators to assess the safety of the investigational product. For approved medications, a copy of the Prescribing Information may be used in place of an Investigator Brochure.

FDA forms to accompany the IND submission: