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HHS/FDA | RIN: 0910-AA97 | Publication ID: Fall 2018 |
Title: Postmarketing Safety Reporting Requirements for Human Drug and Biological Products | |
Abstract:
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). |
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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: Final Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 310 21 CFR 314 21 CFR 600 21 CFR 601 21 CFR 606 | |
Legal Authority: 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 |
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: Jane E. Baluss Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3469 Fax:301 847-8440 Email: jane.baluss@fda.hhs.gov |