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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.

Members of the prescription drug user fee reauthorization negotiating teams are finalizing language for the commitment letter that would extend...

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America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

More from Pathways & Standards

Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews

 
• By Vibha Sharma

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New EU Approvals

 
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America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US