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Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII

 
• By Derrick Gingery

US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.

Clinical Trial
Changes to the FDA's Complex Innovative trial Design (CID) program may be coming in PDUFA VII. • Source: Shutterstock

Drug sponsors balked at increasing user fee funding for the Patient-Focused Drug Development and Complex Innovative trial Design programs, questioning the additional staff proposed to maintain and expand them.

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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
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US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 
• By Derrick Gingery

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

More from Pathways & Standards

Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
• By Sue Sutter

The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.

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