For Industry
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PDUFA Performance Evaluation Reports
Prescription Drug User Fee Act (PDUFA) performance management funds are provided for initiatives targeted to improve the drug review process. Final reports of the major studies and evaluations that were conducted during PDUFA III and PDUFA IV using these funds are provided below.
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PDUFA Performance Evaluation Reports
An Evaluation of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster, Fiscal Years 2009 - 2013 (PDF - 1MB)
(April 2013)Assessment of the Impact of the Electronic Submission and Review Environment on the Efficiency and Effectiveness of the Review of Human Drugs – Final Report (PDF - 5.5MB)
(September 2011)- Planned Review Timelines Assessment -- Final Report
(April 2011) Assessment of GRMPs Implementation (PDF - 1.8MB)Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee Act (PDUFA) IV Workload Adjuster for FY 2009 -- Final Report
(March 2009)Independent Evaluation of FDA's First Cycle Review Performance –- Final Report
(July 2008)Postmarketing Commitments Study Final Report Text Version
(January 2008)CMA Pilot 1 Evaluation and Pilot 2 Preliminary Evaluation Studies -- Final Report Text
(May 2006)Independent Evaluation of FDA's First Cycle Review Performance – Retrospective Analysis Final Report Text
(January 2006)
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