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Closing soon Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2026-N-10165

FDA Seeks Public Input on Statistical Design of Rare Disease Clinical Trials

💬 Comments close in 11 days (Nov 13)

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  1. Proposed / opened

    FDA Seeks Public Input on Statistical Design of Rare Disease Clinical Trials

  2. Related document

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

Briefs in this proceeding

Notable FDA 💬 Comments close in 11 days (Nov 13)

FDA Seeks Public Input on Statistical Design of Rare Disease Clinical Trials

FDA is opening a public docket to gather comments on statistical methods for rare disease clinical investigations ahead of a RISE workshop to inform future guidance. The FDA has established a public docket (2026-18805) to collect comments on statistical considerations for the design of rare...

Sources

Health and Human Services Department, Food and Drug Administration · Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments · Sep 15