Mikaela Naylon Give Kids a Chance Act of 2025

S 3302, the Mikaela Naylon Give Kids a Chance Act of 2025, requires drug manufacturers developing cancer treatments to conduct pediatric-focused research for certain drugs targeting pediatric cancer mechanisms. It amends FDA drug approval processes to mandate molecularly targeted pediatric cancer investigations for drugs with new active ingredients or specific approved combinations, ensuring studies address dosing, safety, and efficacy for children. The bill also extends priority review vouchers (which expedite FDA reviews) for rare pediatric disease treatments until 2030 and mandates GAO studies to evaluate how effectively these incentives spur new pediatric cancer drug development. These changes apply to new drug applications submitted three years after the law's enactment, with reports due to Congress at 6, 8, and 10 years.