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HHS/FDA | RIN: 0910-AI61 | Publication ID: Fall 2022 |
Title: Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products | |
Abstract:
The proposed rule would modernize FDA’s regulations on postmarketing safety reporting and pharmacovigilance for human drug and biological products, including blood and blood components, by capturing important new safety-related information, improving the quality and utility of submitted reports, and supporting enhanced alignment with internationally harmonized reporting guidelines. Among other things, the proposed rule would require the submission of certain nonclinical and clinical data to FDA in a periodic safety report, rather than the annual report. The proposed rule also would require application holders for drug products and certain biological products to establish and maintain a pharmacovigilance quality system that reflects the application holder’s unique needs and that may support a more streamlined, flexible approach to satisfying certain postmarketing safety reporting requirements. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 310 21 CFR 314 21 CFR 600 21 CFR 606 | |
Legal Authority: 42 U.S.C. 262 42 U.S.C. 264 42 U.S.C. 300aa-25 21 U.S.C. 321 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 371 21 U.S.C. 374 ... |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Janice L. Weiner Principal Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring, MD 20993-0002 Phone:301 796-3475 Fax:301 847-8440 Email: janice.weiner@fda.hhs.gov |