FDA Proposed Rule: Investigational New Drug Applications: Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement or Cosmetic

The purpose of this overview is to explain a proposed U.S. Food and Drug Administration (FDA) rule that would create formal exemptions from investigational new drug (IND) requirements for certain clinical studies of products lawfully marketed as conventional foods, dietary supplements, or cosmetics.

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