Food and Drug Administration Amendments Act (FDAAA) of 2007
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.
What is FDA Doing?
FDAAA Implementation Chart FDAAA Implementation - Highlights Two Years After Enactment FDAAA Implementation – Highlights One Year After Enactment Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 Renewed Legislation Improves Safety of FDA-Regulated Products[ARCHIVED]
FDAAA Certification to Accompany Drug, Biological Product, and Device Applications or Submissions 12/12/07 Federal Register Notice Certification FDA Seeks Nominations for Reagan-Udall Foundation[ARCHIVED] September 27, 2007 Transcript of FDA Press Conference on Food and Drug Administration Amendments Act of 2007(PDF - 54KB) September 27, 2007 Audio for Transcript of FDA Press Conference on Food and Drug Administration Amendments Act of 2007(MP3 - 3.8MB) New Law Ensures Access to Medical Treatments and Information[ARCHIVED] Statement by FDA Commissioner Andrew C. von Eschenbach on Passage of FDA Amendments Act of 2007 (FDAAA)[ARCHIVED]