• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Industry

  • Print
  • Share
  • E-mail

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.