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

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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