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Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments
Comment period open: closes in 27 days (Nov 13, 2026). Comment on Regulations.gov →
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Submit a comment · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect feedback on statistical considerations for rare disease clinical investigations. This docket is open in conjunction with a Rare disease Innovation, Science, and Exploration (RISE) Workshop on the same topic. Feedback is welcome both on the attached pre-read documents and on the content covered in the Workshop itself.
- Document type
- Notice
- Federal Register document number
- 2026-18805
- Published
- Sep 15, 2026
- Action
- Notice; establishment of a public docket; request for information and comments.
- Docket
- FDA-2026-N-10165
- Comments posted on Regulations.gov (at last check)
- 1
- DATES section (from the document)
- Either electronic or written comments on the notice must be submitted by November 13, 2026.
- Topics (auto-tagged)
- Clinical
Source: Federal Register API, document 2026-18805. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.