FDA Grants Hearing To Appeal Avastin Breast Cancer Withdrawal
This article was originally published in The Pink Sheet Daily
Genentech and FDA will argue over revoking the accelerated approval for breast cancer before ODAC, which voted to remove the indication last July.
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Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.
While CBER is often perceived to be as much focused on research as it is on application review, Midthun was central to many key policy debates.