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…
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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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- Canonical URL: https://bidda.com/intelligence/us-fda-amendments-act-2007-fdaaa-pl-110-85
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