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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.

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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.

With the House of Representatives and Senate controlled by different parties that have divergent priorities, additions that could be included...

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The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

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