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HHS/FDA RIN: 0910-AI57 Publication ID: Fall 2020 
Title: ●Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies 
Abstract:

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 analytical and clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies that support human research and 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 16    21 CFR 312    21 CFR 314    21 CFR 320    21 CFR 321    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
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
Timetable:
Action Date FR Cite
NPRM  08/00/2021 
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
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 5215,
Silver Spring, MD 20993-0002
Phone:240 402-4089
Email: brian.folian@fda.hhs.gov