The Scientific EXPERT Act of 2025 establishes a process for science-focused drug development meetings led by the Reagan-Udall Foundation for the FDA.
The Scientific EXPERT Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to create a process for externally led, science-focused drug development meetings (EL-SFDD meetings) led by the Reagan-Udall Foundation for the FDA. These meetings focus on drugs for rare diseases and conditions. The Secretary of Health and Human Services must enter into an arrangement with the Foundation to convene at least four EL-SFDD meetings annually, each addressing a different rare disease or condition.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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