Food and Drug Administration Amendments Act of 2007 | Wikipedia audio article
Channel: wikipedia tts
Date: 2018-12-11

This is an audio version of the Wikipedia Article:
Food and Drug Administration Amendments Act of 2007


00:00:43 1 Title I: Prescription Drug User Fee Amendments of 2007
00:02:46 2 Title II: Medical Device User Fee Amendments of 2007
00:03:55 3 Title III: Pediatric Medical Device Safety and Improvement Act of 2007
00:05:42 4 Title IV: Pediatric Research Equity Act of 2007
00:06:46 5 Title V: Best Pharmaceuticals for Children Act of 2007
00:09:15 6 Title VI: Reagan-Udall Foundation
00:10:42 7 Title VII: Conflicts of Interest
00:11:31 8 Title VIII: Clinical Trials Databases
00:12:14 9 Title IX: Enhanced Authorities Regarding Postmarket Safety of Drugs
00:16:01 10 Title X: Food Safety
00:17:17 11 Title XI: Other Provisions
00:18:38 11.1 Priority review voucher program
00:19:24 12 See also



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SUMMARY
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President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program.