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Topics on this Page
On
September 27, 2007, President George W. Bush signed into
law H.R. 3580, the Food and Drug Administration Amendments
Act of 2007. 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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