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Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments

16 October 2026

In plain English

FDA announces a public meeting on the Fit-for-Purpose Rare Disease Framework Initiative and opens a public docket for comments on rare disease therapy development and review.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
16 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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 c
The full text is at the source

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