Innovation in Pediatric Drugs Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to modify pediatric study requirements for orphan drugs.
The Innovation in Pediatric Drugs Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to modify pediatric study requirements for orphan drugs. It ensures equal accountability for pediatric study requirements, applies pediatric research requirements to orphan drugs, and maintains a list of adult-related diseases and conditions for which pediatric studies are impossible or highly impracticable. The bill also mandates the Secretary of Health and Human Services to issue guidance and hold a public meeting to inform final guidance.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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