FDA, in partnership with the Reagan-Udall Foundation for the FDA, convenes a hybrid meeting exploring the patient voice in rare disease medical product development — , 1:00–5:00 p.m. ET, in person at FDA White Oak or online via Zoom.
Date and format
- Date: 16 October 2026, 1:00–5:00 p.m. ET
- Format: hybrid — in person at FDA White Oak (Building 31, Room 1503) or online via Zoom
- Convener: FDA, in partnership with the Reagan-Udall Foundation for the FDA
- Registration: via FDA's meeting page; fee not stated in the sources reviewed
What it covers
The meeting explores where the patient voice is currently sought across the rare disease medical product development timeline — spanning drugs, biologics and devices — what impact that engagement has had, and where additional opportunities exist for patients to shape the product development process. Insights from the discussion are intended to inform recommendations for both product developers and regulators as they advance patient-centered approaches in their own work.
Who should attend
FDA aims this at patients and patient advocates in the rare disease community, alongside regulatory affairs, clinical and product development professionals working on rare disease programs who want to understand how patient input is gathered and used across the development timeline.
The meeting continues FDA's broader rare disease patient-engagement work, alongside the earlier Patient-Focused Drug Development meeting on nonhealing chronic wounds and the agency's Pediatric Advisory Committee sessions; the full events directory lists every FDA session we have verified.
Frequently asked questions
When and where is the Patient Voice in Rare Disease Medical Product Development meeting?
16 October 2026, 1:00–5:00 p.m. ET. It can be attended in person at the FDA White Oak Campus (Building 31, Room 1503, Silver Spring, MD) or online via Zoom.
Who is convening the meeting?
FDA, in partnership with the Reagan-Udall Foundation for the FDA, an independent nonprofit created by Congress to advance FDA's regulatory science mission.
What does the meeting cover?
Where the patient voice is currently sought across the rare disease medical product development timeline (drugs, biologics and devices), its impact so far, and additional opportunities for patients to engage in that process.
Who should attend?
Patients and patient advocates in the rare disease community, along with regulatory, clinical and drug/device development professionals working on rare disease programs, per FDA's own meeting page.
Is there a fee?
FDA's page does not state a registration fee for this public meeting. It is not stated here because it was not confirmed in the sources reviewed — check FDA's own registration page before assuming it is free.
Sources & further reading
- FDA. Patient Voice in Rare Disease Medical Product Development, 10/16/2026. fda.gov
- George Washington University Calendar. FDA Public Meeting for Rare Disease Month 2026. calendar.gwu.edu
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of FDA's own page rather than a direct fetch, because this session's network egress could not reach fda.gov directly — confirm date, format and registration with FDA before making plans. Last verified 18 September 2026.
