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, PDUFA IV, and PDUFA V using these funds are provided below. 

PDUFA Performance Evaluation Reports

• Assessment of Impact of Electronic Submissions and Data Standards on the Efficiency and Other Performance Attributes of the Human Drug Review Process
• Prescription Drug User Fee Act (PDUFA) Workload Adjuster Evaluation, Final Report, Fiscal Years 2009 – 2015
• An Evaluation of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster, Fiscal Years 2009 - 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
• Planned Review Timelines Assessment -- Final Report
• Assessment of GRMPs Implementation
• 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
• Independent Evaluation of FDA's First Cycle Review Performance –- Final Report
• Postmarketing Commitments Study Final Report Text Version
• CMA Pilot 1 Evaluation and Pilot 2 Preliminary Evaluation Studies -- Final Report Text
• Independent Evaluation of FDA's First Cycle Review Performance – Retrospective Analysis Final Report Text