0910-AH07 201804 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.  The proposed rule would also streamline some IND application requirements for certain studies that do not qualify for the new exemption.

]]> 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 Mickey Parish Senior Science Advisor 0910 Food and Drug Administration FDA 240 402-1728 mickey.parish@fda.hhs.gov 5100 Campus Drive, Room 4A004, College Park MD 20740