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Virtual

Mar 29, 2023 10:00 AM - Mar 31, 2023 4:15 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 3: Recent updates on FDA User Fee Amendments

Session Chair(s)

Hye Soo  Cho, MS

Hye Soo Cho, MS

Statistician

FDA, United States

Satrajit  Roychoudhury, PhD

Satrajit Roychoudhury, PhD

Executive Director, Statistical Research and Innovation

Pfizer, Inc., 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

Prescription Drug User Fee Act (PDUFA VII) Updates

Sylva Heghinian Collins, PhD

FDA, United States

Director, Office of Biostatistics, FDA, CDER

Jacqueline A. Corrigan-Curay, JD, MD

Biosimilar User Fee Act (BsUFA III) and Generic Drug User Fee Act (GDUFA III) Updates

Jacqueline A. Corrigan-Curay, JD, MD

FDA, United States

Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)

Donna  Boyce, MS, RAC

Panelists

Donna Boyce, MS, RAC

Pfizer Inc, United States

Head and Senior Vice President of Global Regulatory Sciences

Venkat  Sethuraman, PhD, MBA, MS

Panelist

Venkat Sethuraman, PhD, MBA, MS

Bristol Myers Squibb, United States

Senior Vice President, Global Biometrics and Data Sciences

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