What US FDA Amendments Act 2007 FDAAA Public Law 110-85 REMS Risk Evaluation and Mitigation Strategies Post-Market Safety Authority Clinical Trial Registration and User Fees requires
The Food and Drug Administration Amendments Act of 2007 Public Law 110-85 enacted on 27 September 2007 substantially expands FDA authority to ensure post-market drug safety organised in nine titles covering Title I Prescription Drug User Fee Act IV (PDUFA IV) reauthorising FDA user fees through fiscal year 2012 Title II Medical Device User Fee Act II reauthorising medical device user fees Title III Pediatric Medical Device Safety and Improvement Act establishing pediatric medical device tracking Title IV Pediatric Research Equity Act and Best Pharmaceuticals for Children Act reauthorisation requiring pediatric studies of drugs Title V Reagan-Udall Foundation establishing the public-private foundation for FDA modernisation Title VI Reportable Food Registry Title VII Conflicts of Interest reforms for FDA advisory committees Title VIII Citizen Petitions reforms requiring FDA response within 150 days and Title IX Drug Safety expanding FDA post-market authority including Section 901 establishing Risk Evaluation and Mitigation Strategies (REMS) under section 505-1 of the FD&C Act Section 902 active risk identification and analysis Section 903 labelling changes ordered by FDA Section 904 post-market studies and clinical trials Section 905 FDAAA clinical trial registration in ClinicalTrials.gov Section 906 medication guides Section 907 advisory committee meetings Section 908 pharmacovigilance system and Section 909 enforcement including civil monetary penalties for noncompliance.
Pillar: Pharmaceuticals & Life Sciences · Authority: US Congress and US Food and Drug Administration Center for Drug Evaluation and Research · Version: 1.0.0 · Last updated:
Primary source: https://www.congress.gov/110/plaws/publ85/PLAW-110publ85.pdf
SHA-256 integrity: b18f8b64691ef9a745408bfe06567154bff90c1c52f1118b7be206a941d423e1
Primary Citations — 8 traced to source
- FDA Amendments Act of 2007 Public Law 110-85 https://www.congress.gov/110/plaws/publ85/PLAW-110publ85.pdf
- FD&C Act section 505-1 REMS https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title21-section355-1&num=0&edition=prelim
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