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S 932119th CongressIntroduced
Give Kids a Chance Act of 2025
Introduced: Oct 31, 2025
Healthcare
Standard Summary
Comprehensive overview in 1-2 paragraphs
The Give Kids a Chance Act of 2025 amends the Federal Food Drug and Cosmetic Act to mandate molecularly targeted pediatric cancer investigations for applicable drug applications requiring FDA review and extends the rare pediatric disease priority review voucher program through 2029 while imposing new reporting requirements on drug developers and regulatory agencies.
Key Points
- 1Requires pharmaceutical companies to conduct molecularly targeted pediatric cancer investigations for drugs affecting molecular pathways relevant to pediatric cancers with specific clinical data collection standards for dosing and safety across age groups.
- 2Extends the rare pediatric disease priority review voucher program until September 30 2029 allowing companies developing treatments for rare pediatric conditions to receive expedited FDA review for another drug application.
- 3Mandates the FDA to issue implementation guidance within 12 months and requires comprehensive congressional reports on program effectiveness including GAO studies on pediatric cancer drug development impacts and voucher program outcomes.
Impact Areas
Pediatric cancer patients and familiesPharmaceutical industry drug developersFDA regulatory review processesChildren with rare pediatric diseases
Generated by legislative-analyst-v3 on Oct 31, 2025