FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: FIT-FOR-PURPOSE RARE DISEASE FRAMEWORK INITIATIVE; PUBLIC MEETING; REQUEST FOR INFORMATION AND COMMENTS

WASHINGTON, Oct. 16 -- Food and Drug Administration has issued a notice called: Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments.

The notice was published in the Federal Register on Oct. 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and regulatory review of rare disease therapies. There will be an opportunity to request t...