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FDA Reforms Missed By FDORA Could Find Vehicle In Animal Drug User Fee, Pandemic Bills

 
• By Derrick Gingery

The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.

US flags perspectives
The FDA also wants the must-pass ADUFA and AGDUFA bills to pass well before the programs' expiration date. • Source: Shutterstock

A lesser known must-pass bill coming up this year could be one of the potential vehicles for US Food and Drug Administration reforms that were left out of the 2022 human drug, biosimilar and device user fee reauthorization package.

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US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
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The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

New EU Approvals

 
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