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HHS/FDA RIN: 0910-AI57 Publication ID: Fall 2023 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 16    21 CFR 312    21 CFR 314    21 CFR 320    21 CFR 321    21 CFR 601   
Legal Authority: 21 U.S.C. 355    21 U.S.C. 371    21 U.S.C. 374    42 U.S.C. 262   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/00/2024 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Brian Joseph Folian
Supervisory Biologist
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 22, Room 1440,
Silver Spring, MD 20993-0002
Phone:240 402-4089