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Event Title
Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub
October 16, 2024

Date:
October 16, 2024
Time:
10:00 a.m. - 2:30 p.m. ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


FDA’s Rare Disease Innovation Hub, in collaboration with the Reagan-Udall Foundation for the FDA, will host a public meeting on October 16, 2024. The meeting will bring together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss how the recently announced Rare Disease Innovation Hub can best engage with members of the rare disease community and prioritize its work.

During this public meeting, FDA seeks to gather stakeholder input in the following areas:

  • Cross-cutting rare disease-related, scientific, regulatory, or policy issues (those not related to a particular disease or condition) that should be prioritized for consideration by the Rare Disease Innovation Hub
  • Rare disease-specific (but not application-specific) scientific, regulatory, or policy issues that should be prioritized for consideration by the Rare Disease Innovation Hub
  • Rare disease-related activities or initiatives currently being undertaken independently by CDER or CBER that you believe would benefit from being undertaken by the Rare Disease Innovation Hub as a joint activity
  • Approaches that the Rare Disease Innovation Hub should follow for engagement with patients and caregiver groups, industry organizations, and scientific/academic organizations

Registrants may request to make oral presentations during the meeting when registering.  See meeting Federal Register Notice for further information regarding submitting comments to the docket.

This is a hybrid event with options to participate in-person or virtually. Registration is free and in-person attendance is based on space availability, with priority given to early registrants. For in-person attendees, the venue address is 10903 New Hampshire Ave., Building 31 – Great Room, Silver Spring, MD 20993.

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