On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 which included the reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA). The reauthorization of PDUFA (through FY 2012) significantly broadened and upgraded the agency's drug safety program, increased resources for review of television drug advertising, and facilitated more efficient development of safe and effective new medications for the American public.
PDUFA IV Legislation
- Recommendations Transmitted to Congress -- letters dated March 16, 2007 (PDF - 2.2MB)
FDA Implementation of PDUFA III Public Accountability Provisions in Developing Recommendations for PDUFA IV Letter to the Honorable Mr. Dingell Concerning PDUFA IV(PDF - 41KB)
Text Version of Letter to the Honorable Mr. Dingell Concerning PDUFA IV
- Section A: PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2010
PDUFA IV Drug Safety Five-Year Plan (December 2008)(PDF - 121KB) PDUFA IV Public Meetings[ARCHIVED]
Information about the three major public meetings that were held for PDUFA IV