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Pediatric Study Requirements For Cancer Have FDA Support, But Pose Industry Challenges

 
• By Sue Sutter

Biosimilars could face new requirements if RACE for Children Act expands PREA to molecularly targeted cancer drugs approved for adult indications; other stakeholders also worry about general feasibility.

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The next Prescription Drug User Fee Act reauthorization could provide a platform for legislation expanding the Pediatric Research Equity Act's reach into childhood cancer.

The Research to Accelerate Cures and Equity for Children Act, also known as the RACE for Children Act,...

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House Gives US FDA More Non-User Fee Funds Than Requested

 
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A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

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What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
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ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

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