Avastin’s Legacy May Be Quicker Withdrawal Process For New Approval Pathways
This article was originally published in Pharmaceutical Approvals Monthly
CBER Director Karen Midthun, who served as the FDA commissioner’s designee for the hearing on bevacizumab’s breast cancer claim, says the Avastin proceedings required “tremendous resources and time.” Consequently, any new drug approval route should include a mechanism for abbreviated withdrawal, she says.
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