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Pediatric Study Timelines Could Change Under Senate PDUFA Bill

 
• By Sue Sutter

Provisions aimed at earlier planning and completion of pediatric studies are part of user fee legislative package Senate committee will vote on May 10; measure also calls for FDA guidance on pediatric studies of molecularly targeted cancer drugs but does not require such trials.

Measures aimed at earlier planning and completion of pediatric drug studies have been rolled into the proposed Senate legislative package reauthorizing FDA’s drug, biosimilar and medical device programs.

The Senate Health, Education, Labor and Pensions (HELP) Committee released a manager's amendment of the FDA Reauthorization Act...

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