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Pediatric Study Compliance Could Face Scrutiny In PDUFA Renewal

 
• By Sue Sutter

FDA says compliance is on par with other postmarketing requirements, but jury is still out on whether public posting of noncompliance letters has been effective tool to ensure timely trial completion.

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Questions around industry compliance with postmarketing requirements in the Pediatric Research Equity Act (PREA), and whether FDA has sufficient enforcement tools and incentives to ensure studies are timely completed, could be up for discussion in the next reauthorization of the Prescription Drug User Fee Act.

A recent Health and Human Services' Office of Inspector General report suggested PREA studies represented a high percentage of FDA...

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Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

EU Ups Ante On Stockpiling For Crises

 
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The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
• By Sarah Karlin-Smith

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 
• By Francesca Bruce

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

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Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

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England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 
• By Neena Brizmohun

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.