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U.S. Department of Health and Human Services

Regulatory Information

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Full Text of FDAAA Law

Food and Drug Administration Amendments Act of 2007
Public Law 110-85 (September 27, 2007) 

Title I: Prescription Drug User Fee Amendments of 2007
Title II: Medical Device User Fee Amendments of 2007
Title III: Pediatric Medical Device Safety and Improvement Act of 2007
Title IV: Pediatric Research Equity Act of 2007
Title V: Best Pharmaceuticals for Children Act of 2007
Title VI: Reagan-Udall Foundation
Title VII: Conflicts of Interest
Title VIII: Clinical Trial Databases
Title IX: Enhanced Authorities Regarding Postmarket Safety of Drugs
Title X: Food Safety
Title XI: Other Provisions