Q&A: FDA's Peter Marks ready to encourage more accelerated approvals for rare diseases
FDA biologics center director Peter Marks said the agency plans to encourage sponsors to use the accelerated approval pathway, particularly for rare disease treatments, as the agency also moves ahead with an Operation Warp Speed-like pilot for rare diseases later this year.
In an expansive interview with Endpoints News, Marks said he expects to see more accelerated approval applications in the rare disease gene therapy space as well as potentially in cell therapies. Marks said the rare disease Operation Warp Speed effort, which he announced in February, will “start small” to make sure the agency can work closely with the first round of participants.
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