0910-AH07 201810 The Regulatory Plan and the 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 Requirements for Conventional Foods, Dietary Supplements, and Cosmetics

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 proposed 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 lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review.  

]]> Other Significant Previously Published in The Unified Agenda Proposed 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 04/00/2019 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