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In this section: Development Resources

Statutes and Regulations

FDA Reauthorization Act (2017)
See Title V for Pediatric Changes
FDA Safety and Innovation Act (2012)
See Title V for pediatric drugs and devices
Food and Drug Administration Amendments Act of 2007 (PDF - 383 KB)
See Title IV for full text of the Pediatric Research Equity Act of 2007 and Title V for full text of the Best Pharmaceuticals for Children Act of 2007.
Pediatric Research Equity Act of 2003 (Public Law No: 108-155)
Best Pharmaceuticals for Children Act of 2002 (Public Law No: 107-109)
PREA Retrospective Review (PDF - 281KB) 1/14/2010
Rare Pediatric Disease Priority Review Voucher Program
Section 908 of FDASIA

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