CDER leaders ready to implement swifter accelerated approval withdrawal process
With the long Makena accelerated approval withdrawal saga fresh in their minds, both the director of the FDA’s Center for Drug Evaluation and Research (CDER) and her deputy discussed upcoming guidance on how these withdrawals will move more quickly.
Thanks to the Food and Drug Omnibus Reform Act (FDORA), FDA has new authority to not only require confirmatory trials to begin prior to an accelerated approval but also has Congress’ blessing to speed up the withdrawal process when a confirmatory trial does not show clinical benefit.
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