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U.S. Department of Health and Human Services

Drugs

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IND Applications for Clinical Investigations: Contents and Format

The general contents and format of IND application are described in the Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (PDF - 41KB)

There is no template for an IND application. However, if the organization of this checklist (PDF - 93KB) is followed, it will help to assure that all the required information has been submitted.