Rare Disease Drug Development (FDA)
Current understanding
To be populated as evidence accumulates.
Evidence log
- 2025-02-24 — Scientific EXPERT Act of 2025: Scientific EXPERT Act of 2025 (House, introduced/referred to committee) would require FDA, in collaboration with the Reagan-Udall Foundation, to hold at least four externally led scientific meetings per year on rare-disease drug development and to document in approval decisions whether input from those meetings was used in approving a drug or biologic. (novelty: 3)