U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Prescription Drug User Fee Amendments
  5. PDUFA Legislation and Background: PDUFA IV
  1. Prescription Drug User Fee Amendments

PDUFA Legislation and Background: PDUFA IV

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

Background

White Paper

 
Back to Top