Passage of FDAAA of 2007

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.