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On September 27, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007, with (from left to right) HHS Secretary Michael Leavitt, FDA Commissioner Andrew von Eschenbach, and Rep. Joe Barton of Texas in the Oval Office. This new law represents a very significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded. These programs will ensure that FDA staff have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices.
Two other important laws were reauthorized: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Both of these are designed to encourage more research into, and more development of, treatments for children.
Overall, this new law will provide significant benefits for those who develop medical products, and for those who use them.
- Certification of Compliance with Requirements of ClinicialTrials.gov Data Bank Form [pdf, 950 KB] (December 7, 2007)
- Federal Register Notice [TXT] [PDF] [PRE-PUB] (December 12, 2007)
- FDA Seeks Nominations for Reagan-Udall Foundation (October 4, 2007)
- Transcript of FDA Press Conference on FDAAA [pdf, 55 KB] Audio [MP3, 3.77 MB] (September 27, 2007)
- New Law Ensures Access to Medical Treatments and Information (HHS press release, September 27, 2007) [en Español]
- Statement on Congressional passage of FDAAA (September 20, 2007)
- Public Law 110-85 (September 27, 2007)
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