0910-AI61 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products

The proposed rule would modernize FDA’s regulations on postmarketing safety reporting and pharmacovigilance for human drug and biological products by capturing important new safety-related information, improving the quality and utility of submitted reports, and supporting enhanced efficiency and alignment with internationally harmonized reporting guidelines.  The proposed rule also would require application holders for drug products and biological products (other than blood or blood components) to establish and maintain a pharmacovigilance quality system that reflects the application holder’s unique needs and that would support the more streamlined, flexible approach to fulfilling certain postmarketing safety reporting requirements

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 314 21 CFR 600 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 ... No NPRM 03/00/2026 YES Businesses None No Yes No Janice Weiner L. Principal Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3475 301 847-8440 janice.weiner@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring MD 20993-0002