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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. |
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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 |
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Timetable:
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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 51, Room 5215, Silver Spring, MD 20993-0002 Phone:240 402-4089 Email: brian.folian@fda.hhs.gov |