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PDUFA Legislation and Background: PDUFA IV

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PDUFA IV Legislation

Food and Drug Administration Amendments Act (FDAAA) of 2007

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Background

Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety
FDA News Release, 3/23/07
Recommendations Transmitted to Congress -- letters dated March 17, 2007 (PDF - 2293KB)
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
Text Version of Letter to the Honorable Mr. Dingell Concerning PDUFA IV
SECTION A: PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2008 THROUGH 2012
PDUFA IV Drug Safety Five-Year Plan (December 2008) (PDF - 121KB)

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White Paper

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

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