0910-AH07 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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

Researchers conducting studies of FDA-regulated products involving human subjects must, in some circumstances, meet requirements set out in FDA’s Investigational New Drug (IND) Application regulations. The rule is intended to broaden the regulatory criteria for studies exempt from IND requirements and provide clarity and consistency regarding when studies evaluating drug uses of products that are already lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review.  

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Deregulatory 21 CFR 312 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 371 42 U.S.C. 262 21 U.S.C. 360bbb No NPRM 12/09/2022 87 FR 75536 NPRM Comment Period End 03/09/2023 Final Rule 10/00/2025 No None No No No Brian Pendleton L. Senior Policy Advisor 0910 Food and Drug Administration FDA 301 796-4614 301 847-3541 brian.pendleton@fda.hhs.gov Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002