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HHS/FDA RIN: 0910-AI57 Publication ID: Fall 2021 
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 analytical and clinical pharmacology, 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: Other Significant 
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 314    21 CFR 320    21 CFR 321    21 CFR 601    ...     (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

Statement of Need:

FDA receives clinical pharmacology and clinical and analytical bioavailability (BA) and bioequivalence (BE) study data in support of new and abbreviated new drug applications, and biological license applications. Our ability to ensure studies supporting those applications are reliable and valid, including data reliability and human subject protection, is severely limited because our regulations governing BA and BE studies at 21 CFR part 320 lack basic study conduct requirements necessary for the Agency to verify study data reliability. Current part 320 does not describe specific responsibilities for persons involved in the conduct of clinical and analytical BA and BE studies, recordkeeping and record retention requirements, standing operating procedures, or compliance provisions. The proposed rule would revise part 320 and establish a new part 321 to codify the Agency’s expectations, and industry best practices, for the conduct of clinical pharmacology and clinical and analytical BA and BE studies for human drug and biological product marketing applications.

Summary of the Legal Basis:

FDA’s proposed revisions to the regulations regarding the conduct of clinical pharmacology and clinical and analytical BA and BE are authorized by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 371 and 374) and by the Public Health Service Act (42 U.S.C. 262).


FDA considered providing guidance to applicants and their contractors that conduct and submits clinical pharmacology and clinical and analytical BA and BE studies to the Agency in support of marketing applications.  

Anticipated Costs and Benefits:

The benefits of the proposed rule would be increased clarity to industry on study conduct expectations that should improve study quality and thereby, to the extent possible, result in fewer study rejections due to deficiencies identified by Agency inspections, and thus promote faster application approvals. Also, potential benefit to patients by increasing the speed in which new human drug and biological products are approved to market. The costs would stem from the proposed rule establishing recordkeeping requirements and procedures and processes requirements that applicants and their contractors would need to meet.  These proposed requirements are in-line with current industry best practices.


The current regulatory framework does not adequately describe FDA’s expectations for the conduct clinical pharmacology and clinical and analytical BA and BE studies to ensure industry performs those studies in a consistent and reliable manner. The proposed rule would establish basic study conduct expectations to ensure study reliability, including data reliability and human subject protection.

Action Date FR Cite
NPRM  06/00/2022 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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