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About FDA
Studies
In conjunction with the 2002 Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures (PDUFA III Goals), the Food and Drug Administration (FDA) agreed to meet specific performance goals to improve the effectiveness and efficiency of FDA review of New Drug Applications (NDAs) and Biologic License Applications (BLAs). Similar goals were included in the PDUFA IV reauthorization.
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PDUFA III Performance Evaluation Reports
- Independent Evaluation of FDA's First Cycle Review Performance – Final Report (PDF - 655KB)
- Postmarketing Commitments Study - Final Report (PDF - 369KB)
- CMA Pilot 1 Evaluation and Pilot 2 Preliminary Evaluation Studies - Final Report (PDF - 499KB)
- Independent Evaluation of FDA's First Cycle Review Performance – Retrospective Analysis Final Report (PDF - 701KB)
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