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FDA STATEMENT

FOR IMMEDIATE RELEASE
September 20, 2007

Media Inquiries:
Heidi Rebello, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

Statement by FDA Commissioner Andrew C. von Eschenbach on Passage of FDA Amendments Act of 2007 (FDAAA)

We at FDA are pleased that Congress has passed the FDA Amendments Act of 2007 and thank the Members of Congress and their staff for all their hard work on this important accomplishment.

We are particularly pleased that Congress has completed the reauthorizations of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) — two programs accounting for nearly one quarter of FDA's annual budget. Over the past years, the PDUFA and MDUFMA programs have resulted in significant public health gains by making safe and effective, yet increasingly complex, medications and medical devices available to patients faster than was previously possible.

The legislation also includes the reauthorizations of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act — two statutes that have provided invaluable information to the agency about medical products' interaction with pediatric populations.

These programs are vitally important to the agency and its continued ability to protect and promote the public health.  We look forward to working towards implementation of this legislation.

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