0910-AI57 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies

FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA's study conduct expectations for clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies that support marketing applications for human drug and biological products. The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies. This regulation would align with FDA's other good practice regulations, would also be consistent with current industry best practices, and would harmonize the regulations more closely with related international regulatory expectations.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 16 21 CFR 314 21 CFR 320 21 CFR 321 21 U.S.C. 355 21 U.S.C. 371 21 U.S.C. 374 42 U.S.C. 262 No NPRM 04/00/2024 Yes Businesses Federal No Undetermined Yes No Brian Joseph Folian Supervisory Biologist 0910 Food and Drug Administration FDA 240 402-4089 brian.folian@fda.hhs.gov 10903 New Hampshire Avenue, Building 22, Room 1440, Silver Spring MD 20993-0002