Mikaela Naylon Give Kids a Chance Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to enhance pediatric cancer drug development.
The Mikaela Naylon Give Kids a Chance Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to enhance pediatric cancer drug development. It modifies the criteria for molecularly targeted pediatric cancer investigations, requiring them for drugs with a single new active ingredient or a combination of previously approved active ingredients for adult cancer. The Act also extends the authority to issue priority review vouchers for rare pediatric diseases until September 30, 2030.
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