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Event Title
FDA Rare Disease Framework Initiative Public Meeting
October 28, 2026

Date:
October 28, 2026
Time:
1:00 p.m. - 5:00 p.m. ET

Location

Attend In Person or Online via Zoom

In Person: 
FDA White Oak Campus
10903 New Hampshire Avenue
Building 2, Room 2047
Silver Spring, MD 20993
United States

On October 28, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to seek input related to the FDA’s Rare Disease Framework Initiative to reimagine the agency’s approach to rare disease drug development. The intent of this new initiative is to develop a fit-for-purpose Framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type, and the evidence that realistically can be generated in small patient populations. 

The public meeting will be an opportunity for members of the rare disease community – including patients, disease advocates, sponsors, and others – to provide input on the direction and focus of the Framework. Insights from the public’s remarks will inform the agency’s upcoming work. 

The FDA welcomes all feedback related to the Framework Initiative and in particular seeks input on the following topic areas: 

  1. Fit-for-purpose review of rare disease therapies based on attainable evidence, particular disease state, and population. 
  2. FDA consistency and predictability of drug development and review regulatory requirements.  
  3. FDA engagements with external parties – including patients, disease experts, and researchers – to inform review decision-making. 
  4. Considerations for chemistry, manufacturing, and controls (CMC) specific to rare disease therapies.
     
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