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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Maarten Meulenbelt of law firm Sidley Austin explains the pricing challenges that face pharmaceutical companies in Europe during the remainder of 2022 and how they may have to adjust their strategies in order to succeed.
User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.
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.