Comments to FDA: INDs - Determining Whether Human Research Studies Can Be Conducted Without an IND

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Letter | Jan 11, 2011

Docket Number:
FDA-2010-D-0503

Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application.” These comments are focused on issues related to dietary supplements as referenced in the draft guidance.