FDA’s Rare Disease Day 2026 – An Event for Patients
U.S. Food and Drug Administration Rare Disease Day (virtual) · February 23, 2026
FDA Rare Disease Day 2026 (virtual): agency leaders, center staff, patient advocates and researchers discussed FDA initiatives to accelerate rare-disease product development — including LEADER3D, the Rare Disease Innovation Hub, CBER/CDRH/CDER programs, a new "plausible mechanism" draft guidance for individualized therapies, expanded use of real‑world evidence, and AI tools for regulatory review.
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