Home » FDA Official: Agency May Need Accelerated Withdrawal Process
FDA Official: Agency May Need Accelerated Withdrawal Process
The FDA should consider a speedier way to withdraw indications granted under accelerated approval in light of the recent resource-intensive, time-consuming effort to revoke the metastatic breast cancer (MBC) indication for Genentech’s Avastin, CBER Director Karen Midthun says.
Washington Drug Letter
Washington Drug Letter
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