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PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI
Session Chair(s)
Kim Quaintance-Lunn
Vice President, Head of Regulatory Science and Execution
Alexion, United States
Development and approval timelines for drugs and therapeutic biologic products affect us all. This will be the first reauthorization occurring in parallel with a new Congress and a new administration. This session will focus on how PDUFA has affected both the regulator and regulated industry and what we can expect in the sixth iteration of the agreement.
Learning Objective : Discuss a historical review of PDUFA from expediting approvals to expediting development; Identify what's new in PDUFA VI and the impact on sponsor and regulator.
Speaker(s)
Panelist
Theresa Mullin, PHD
FDA, United States
Associate Center Director - CDER
FDA Perspective
Patrick Frey
Neurocrine Biosciences, United States
Senior Director, Regulatory Policy
Industry Perspective
Sandy Milligan, JD, MD
Innovex Strategies, United States
Board of Director Member, Gossamer Bio; Principal
Panelist
Lucy Vereshchagina, PHD
PhRMA, United States
Vice President, Science and Regulatory Advocacy