FDA, facilitated by the Reagan-Udall Foundation for the FDA, opens its new Fit-for-Purpose Rare Disease Framework Initiative to public input — , 1:00–5:00 p.m. ET, in person at FDA White Oak or online via Zoom.

Date and format

  • Date: 28 October 2026, 1:00–5:00 p.m. ET
  • Format: hybrid — in person at FDA White Oak (Building 2, Room 2047; non-FDA entrance via Building 1) or online via Zoom
  • Convener: FDA, facilitated by the Reagan-Udall Foundation for the FDA
  • Comment deadline: 11 December 2026, docket FDA-2026-N-12214 (separate from meeting attendance)

What it covers

FDA's Rare Disease Innovation Hub is building a fit-for-purpose, holistic framework for developing and reviewing drugs, biologics and devices for rare diseases — populations too small for the trial designs and evidence standards built around common conditions. This public meeting is the agency's first formal step to gather input from patients, sponsors and other stakeholders on the Framework's direction and focus, ahead of further sector-specific roundtables and requests for information.

Who should attend

Rare disease drug, biologic and device developers shaping trial design and evidence strategy; regulatory affairs and clinical leads tracking where FDA is headed on small-cohort review; and patient advocates who want a direct line into how the Framework takes shape. The meeting continues FDA's rare disease engagement alongside its earlier Patient Voice in Rare Disease Medical Product Development meeting; the full events directory lists every FDA session we have verified.

Frequently asked questions

When and where is the FDA Rare Disease Framework Initiative public meeting?

28 October 2026, 1:00–5:00 p.m. ET. It is hybrid: in person at the FDA White Oak Campus (White Oak Conference Center, Building 2, Room 2047, Silver Spring, MD) or online via Zoom.

Who is convening the meeting?

FDA, facilitated by the Reagan-Udall Foundation for the FDA, an independent nonprofit created by Congress to advance FDA's regulatory science mission.

What is the Fit-for-Purpose Rare Disease Framework Initiative?

An FDA effort, led by its Rare Disease Innovation Hub, to build a holistic framework for developing and reviewing rare disease therapies suited to small patient populations. This meeting gathers input from patients, sponsors and regulators before the agency advances its recommendations.

Can I submit written comments if I can't attend?

Yes. Electronic or written comments on docket FDA-2026-N-12214 are accepted through 11 December 2026, separate from attending the meeting itself.

Is there a fee?

Trade coverage describes this as a free public meeting; FDA's own fee statement was not directly confirmed from the sources reviewed this session — check FDA's registration page before assuming it is free.

Sources & further reading

  1. Federal Register. Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments, docket FDA-2026-N-12214, 10/16/2026. federalregister.gov
  2. FDA. FDA Rare Disease Framework Initiative Public Meeting, 10/28/2026. fda.gov
  3. RAPS. FDA Launches Rare Disease Framework Initiative. raps.org

Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of FDA's own notice and page rather than a direct fetch, because this session's network egress could not reach fda.gov or federalregister.gov directly — confirm date, format and registration with FDA before making plans. Last verified 17 October 2026.