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US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says

 
• By Sue Sutter

The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.

Cars in a row
The Rare Disease Innovation Hub is focused on driving consistency between CBER and CDER decisions. (Shutterstock)
Key Takeaways
  • Despite tremendous staffing turmoil at the FDA, the Rare Disease Innovation Hub is moving ahead with efforts to improve consistency between the drug and biologic centers and provide a central point of contact for rare disease programs.
  • The first of the hub’s RISE workshops is planned for June, and the agency will open a public docket to receive proposals for future meetings.
  • The hub’s goals align with the Trump Administration’s plans for the agency, Amy Comstock Rick said.

Layoffs and other changes sweeping through the US Food and Drug Administration are not expected to delay the kickoff of the Rare Disease Innovation

A June workshop on design of clinical trials for diseases with small and diminishing populations of eligible participants is “still part of the plan,” Amy Comstock Rick, director of strategic coalitions for the hub, said at the Biopharma Congress on 7

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