FDA Rare Disease Framework Initiative Public Meeting - 10/28/2026

FDA and the Reagan-Udall Foundation will hold a hybrid public meeting on October 28, 2026, on the Rare Disease Framework Initiative. FDA is seeking input from patients, advocates, sponsors and others on attainable evidence, review consistency, external expertise and manufacturing considerations.

Why it matters: FDA says public input will inform its framework work, including evidence expectations and engagement with researchers and patients.