Published on: 2022-26728. Proposed rule. 2022-26728. 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
Published on: 2010-24296. Final rule. 2010-24296. Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Published on: E8-9200. Final rule. E8-9200. Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application