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March 22, 2023 - Real Endpoints

Mar 22, 2023

Top FDA official: Agency needs to start using accelerated approval for gene therapies.

At the recent annual meeting of the Muscular Dystrophy Association, Peter Marks, head of the Center for Biologics Evaluation and Research, noted the importance of using the accelerated approval channel for gene therapies: "We can’t be so careful about our approvals under accelerated approval that we prevent potentially lifesaving therapies from getting to market in a timely manner," he said.

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