Mikaela Naylon Give Kids a Chance Act of 2025

Key Provisions

• Expands the types of pediatric cancer drug studies the FDA can require for new medicines, including certain combination treatments.
• These pediatric cancer studies must gather meaningful data on dosing, safety, and how well the drug works for children. They must use forms suitable for different age groups.
• Extends the program that gives drug companies special vouchers to encourage them to develop treatments for rare childhood diseases until September 30, 2030.
• Changes when drug companies would pay a fee for using these rare pediatric disease vouchers, making it due when they submit the drug application.
• The FDA must issue draft guidelines on these pediatric cancer investigation changes within 12 months of the bill becoming law. They will then finalize them after a public comment period.