Give Kids a Chance Act of 2025

This bill aims to get more cancer drugs tested for kids earlier. It lets the FDA require pediatric studies for new, targeted cancer drugs, either on their own or when used with certain standard treatments. These studies must collect real, kid-focused data on dosing, safety, and early signs that the drug works, using forms children of different ages can take. The FDA must set clear guidance for companies on how to do this. The new study requirements start three years after the law is passed, giving time to prepare .

The bill also keeps the “priority review voucher” program for rare pediatric diseases going through September 30, 2029. These vouchers speed up FDA review for a future drug and are valuable to companies. The bill clarifies when fees are due and orders a federal study to check if these vouchers are actually helping bring more rare pediatric treatments to patients .

• Who is affected: Children with cancer; families; drug makers developing cancer treatments; the FDA .
• What changes: FDA can require stronger, earlier pediatric cancer studies; clearer rules and timelines; extended rare pediatric voucher program and evaluation of its impact .
• When: FDA guidance due within 12 months; pediatric study rules apply to applications submitted 3 years after enactment; voucher program extended through 2029; reports on progress and effectiveness due over the next 5–10 years .