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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced March 11, 2025 by Markwayne Mullin · Last progress March 11, 2025
Changes FDA rules so certain molecularly targeted cancer drugs must include pediatric studies that show meaningful dosing, safety, and early effectiveness; it limits when combination‑drug pediatric studies can be required and sets deadlines for FDA guidance and congressional reports. It also extends and adjusts the rare pediatric disease priority review voucher program, changes when the voucher user fee is paid, and requires a GAO study of the voucher program within five years.