Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal
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.
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A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.
Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.
Meetings have continued to be sparse through 2021, but there will end up being nearly as many panels on withdrawing approved uses as on approving new ones.