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BioWorld - Thursday, December 25, 2025
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Home » US FDA Rare Disease Hub an answer to regulatory challenges?
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US FDA Rare Disease Hub an answer to regulatory challenges?

Oct. 16, 2024
By Mari Serebrov
Coming on the heels of an advisory committee in which the U.S. FDA and its independent advisers grappled with trying to fit an ultra-rare disease development program into the confines of the agency’s “significant evidence” requirements, an Oct. 16 public meeting on a Rare Disease Innovation Hub the agency is setting up seemed like a welcome step in the right direction for rare disease patients, their caregivers and companies working in the space.
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