Prescription Drug User Fee Act (PDUFA) IV

The Food and Drug Administration has proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency’s drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.

• Food and Drug Administration Amendments Act of 2007 Signed into Law (9/27/2007)
• Food and Drug Administration Act of 2007 (9/27/2007)

Background Information

• FDA News Release: Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety (issued 3/23/2007)
  
• Recommendations Transmitted to Congress letters dated March 16, 2007

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Date created: September 28, 2007

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