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Product safetyFDAUnited StatesImports

Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments

15 September 2026

In plain English

FDA is opening a public docket to gather comments on statistical considerations for designing rare disease clinical investigations, alongside a related RISE Workshop.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
15 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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.

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