The biggest challenge facing the FDA’s new Rare Disease Innovation Hub

  • STAT | by: Peter J. Pitts |
  • 10/17/2024 12:00 AM

Over the summer, the Food and Drug Administration announced the creation of the Rare Disease Innovation Hub to serve as a point of collaboration and connectivity between the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), patient organizations, and product innovators with the goal of ultimately improving outcomes for patients. But how can it become more than just another case of an aspirational agency press release’s best intentions failing to make a difference?

This came up early and often during the Reagan-Udall Foundation’s public meeting on Wednesday, “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub,” that brought together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss how the hub can best engage with members of the rare disease community and prioritize its work.

 
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