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How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Session Chair(s)
Jeffrey Francer, JD, MPA
Vice President, Head of International Regulatory Affairs and Global Policy
Eli Lilly and Company, United States
As FDA–industry negotiators finalize future performance goals, Congress will shape the next user-fee statute. This session examines how budget politics, workforce shifts, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.
Learning Objective : Describe the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals; Examine how budget pressures and recent reductions in force may affect FDA capacity and review predictability; Assess how leadership priorities to accelerate innovation—including review vouchers, AI, and MAHA initiatives—could influence policy riders and oversight.
Speaker(s)
How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Representative Invited
FDA, United States
How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Barrett Tenbarge, JD
Faegre Drinker, United States
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