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Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and regulatory review of rare disease therapies. There will be an opportunity to request to provide public comments at the meeting. In addition, FDA is establishing a public docket to collect feedback on and input related to its Rare Disease Framework Initiative.
- Document type
- Notice
- Federal Register document number
- 2026-21142
- Published
- Oct 16, 2026
- Action
- Notice of public meeting; request for information and comments.
- Docket
- FDA-2026-N-12214
- Comments posted on Regulations.gov (at last check)
- 4
- DATES section (from the document)
- The hybrid public meeting will be held on October 28, 2026, from 1 to 5 p.m. Eastern Time, and will take place in-person and virtually. Either electronic or written comments must be submitted by December 11, 2026. See the SUPPLEMENTARY INFORMATION section for registration information.
- Topics (auto-tagged)
- Clinical
Source: Federal Register API, document 2026-21142. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.