On December 9, 2022, the FDA published a 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 Agency is proposing to exempt, from the Investigational New Drug application (IND) requirements, clinical trials of drug uses of lawfully marketed foods, dietary supplements, and cosmetics, so long as specific criteria are met.  The Proposed Rule outlines 2 processes for IND exemptions: Self-determined exemptions and FDA-determined exemptions. The comment period for this Proposed Rule closes on March 9, 2023.  To learn more about the proposed processes for IND exemptions and the criteria that must be fulfilled for each, please download our webinar by completing the form below.

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