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Home » Armed with new tools, US FDA picks up pace of accelerated approvals
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Armed with new tools, US FDA picks up pace of accelerated approvals

May 12, 2023
By Mari Serebrov
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
BioWorld Regulatory U.S. CMS FDA

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