PDUFA Legislation and Background: PDUFA IV

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

• Food and Drug Administration Amendments Act (FDAAA) of 2007

Background

• Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety
• Recommendations Transmitted to Congress -- letters dated March 16, 2007
• FDA Implementation of PDUFA III Public Accountability Provisions in Developing Recommendations for PDUFA IV
• Letter to the Honorable Mr. Dingell Concerning PDUFA IV
• 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 (PDF)
• PDUFA IV Public Meetings

White Paper

• White Paper - Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications