Regulatory Counsel

0910-AA97 201804 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 for Human Drug and Biological Products

The final rule would amend the postmarketing safety reporting regulations for human drugs and biological products including blood and blood products in order to better align FDA requirements with guidelines of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Regulatory 21 CFR 310 21 CFR 314 21 CFR 600 21 CFR 601 21 CFR 606 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 242a 42 U.S.C. 262 and 263 42 U.S.C. 263a to 263n 42 U.S.C. 264 42 U.S.C. 300aa 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360b to 360j 21 U.S.C. 361a 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 375 21 U.S.C. 379e 21 U.S.C. 381 No NPRM 03/14/2003 68 FR 12406 NPRM Comment Period Extended 06/18/2003 NPRM Comment Period End 07/14/2003 NPRM Comment Period Extension End 10/14/2003 Final Rule 12/00/2018 Yes Businesses None No Yes No Jane Baluss E. Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3469 301 847-8440 jane.baluss@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002