Innovation in Pediatric Drugs Act of 2024
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Summary
The Innovation in Pediatric Drugs Act of 2024 amends federal drug approval requirements to strengthen pediatric research obligations and provide clarity on enforcement. The bill modifies how the FDA enforces pediatric study requirements, requiring a noncompliance letter and 45-day response period before enforcement action, and limiting penalties to cases where sponsors lack due diligence. It also expands pediatric study requirements to orphan drugs (drugs for rare diseases) when pediatric assessments could provide meaningful therapeutic benefit, while allowing waivers for certain rare disease indications. Additionally, the bill authorizes NIH funding for pediatric research and requires the FDA to issue guidance and maintain lists of diseases qualifying for automatic waivers from pediatric study requirements.
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