Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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 to provide public comments at the meeting. In addition, FDA is establishing a public docket to collect feedback on and input related to its Rare Disease Framework Initiative.
Abstract as published in the Federal Register.
The comment window is still open until December 11, 2026. The comment window is open. Check the document itself for what comments are being solicited on and what weight they carry. Submit comments through the Federal Register document below.
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