Give Kids a Chance Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to enhance pediatric drug development and orphan drug regulations.
The Give Kids a Chance Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to enhance pediatric drug development and orphan drug regulations. It mandates the Comptroller General to study the effectiveness of awarding rare pediatric disease priority vouchers in developing human drug products for rare pediatric diseases. The Act also extends the authority to issue priority review vouchers to encourage treatments for rare pediatric diseases until September 30, 2029.
Included in complete analysis
- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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