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FDA Rare Disease Innovation Hub Future Programming; Request for Comments

Comment period open: closes in 75 days (Dec 31, 2026). Comment on Regulations.gov →

Summary (from the Federal Register abstract)

The Food and Drug Administration (FDA or the Agency) is announcing the following request for comments for a future public workshop series entitled "Rare disease Innovation, Science, and Exploration (RISE) Workshop." The purpose of the public workshops is to focus on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions. The workshops will primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the Agency. The Agency further welcomes comments that highlight general rare disease-related issues of potential interest for the FDA Rare Disease Innovation Hub (Hub) to inform its future activities.

Document type
Notice
Federal Register document number
2026-01903
Published
Jan 30, 2026
Action
Notice; request for comments.
Docket
FDA-2026-N-0131
Comments posted on Regulations.gov (at last check)
18
DATES section (from the document)
Submit either electronic or written comments by December 31, 2026. See the SUPPLEMENTARY INFORMATION section for comment deadlines corresponding to specific workshop sessions.
Topics (auto-tagged)
Clinical

Source: Federal Register API, document 2026-01903. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.