FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: STATISTICAL CONSIDERATIONS FOR THE DESIGN OF RARE DISEASE CLINICAL INVESTIGATIONS; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR INFORMATION AND COMMENTS

WASHINGTON, Sept. 15 -- Food and Drug Administration has issued a notice called: Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments.

The notice was published in the Federal Register on Sept. 15 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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. 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 ...