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S. 3302119th CongressIn committeeLatest action Dec 2, 2025Decoded by AI · checked against the record
Official title: Mikaela Naylon Give Kids a Chance Act of 2025
Introduced:
Read the official bill on Congress.govThe plain-language version leads. The official text is always the reference.
S 3302 requires pediatric cancer studies with new adult cancer drug approvals and extends a rare disease voucher program to 2030.
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S 3302 requires drug companies seeking FDA approval for new adult cancer drugs to also study whether those drugs work against childhood cancers driven by the same genetic or molecular targets. These studies must produce usable data on safe dosing and early effectiveness signs for children of different ages. The bill also extends the Rare Pediatric Disease Priority Review Voucher program through September 2030.
The bill directly affects pharmaceutical and biotech companies developing cancer drugs and the FDA. Children with cancer or rare pediatric diseases, and their families, are the intended population.
Companies that might not otherwise pursue rare childhood disease treatments gain a financial incentive through vouchers that can be used or sold to speed FDA review of a separate drug. Government watchdog agencies must study and report to Congress on whether the rules result in more treatment options for children over time.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: a Senate committee is reviewing it. If the House changes it, it goes back to the Senate before reaching the President.
Latest action: — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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