Regulation & Policy
Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments
Summary: 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.
Key points
- 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.
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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