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Session 3: Recent updates on FDA User Fee Amendments
Session Chair(s)
Hye Soo Cho, MS
Statistician, FDA, United States
Satrajit Roychoudhury, PHD
Executive Director, Statistical Research and Innovation, Pfizer, United States
The US Food & Drug Administration (FDA) collects fees from companies that produce certain products, such as drugs and medical devices. The user fees ensure predictable timelines for the review process and facilitate the availability of safe and effective drugs and products. For most major user fee programs, the FDA and industry negotiate agreements on user fees every five years. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which include the reauthorization of Prescription Drug User Fee Act (PDUFA VII), Biosimilar User Fee Act (BsUFA III), and Generic Drug User Fee Act (GDUFA III) through September 2027. This session will focus on these three-user fee act reauthorizations and speakers will provide details and key updates for each user fee program. In addition to the presentations, we will have a panel discussion between FDA and industry to learn different perspectives and discuss trending topics.
Learning Objective : - Understand FDA’s user fee programs, specifically PDUFA, GDUFA, and BsUFA
- Describe key PDUFA VII updates including launching the Rare Disease Endpoint Advancement (RDEA) Pilot program under PDUFA VII
- Identify key GDUFA III and BsUFA III updates, including enhancing approvals of complex generics and BsUFA III Regulatory Research Pilot Program
Speaker(s)
Sylva Heghinian Collins, PHD
Director, Office of Biostatistics, FDA, CDER, FDA, United States
Prescription Drug User Fee Act (PDUFA VII) Updates
Jacqueline A. Corrigan-Curay, JD, MD
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States
Biosimilar User Fee Act (BsUFA III) and Generic Drug User Fee Act (GDUFA III) Updates
Donna Boyce, MS, RAC
Senior Vice President & Head, Global Regulatory Sciences, Pfizer, United States
Panelists
Venkat Sethuraman, PHD, MBA, MS
Senior Vice President, Global Biometrics and Data Sciences, Bristol Myers Squibb, United States
Panelist
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