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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 in an ADUFA and AGDUFA package likely will be limited

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More from Pathways & Standards

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
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A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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