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Latest From Covis Pharma
Makena: Formal Withdrawal Order Would Provide ‘Greater Certainty,’ Transparency – CDER
Final decision by the Office of Commissioner would provide more certainty than Covis’ proposal to voluntarily withdraw Makena ‘at some point in the future’ and assure that generic versions of the preterm birth prevention drug come off the market at the same time, the US FDA’s drugs center tells the Pink Sheet.
Makena Panel Vote Adversely Influenced By Framing Of Withdrawal Question, Covis Says
‘Ad hoc narrowing’ of the final voting question by hearing officer Celia Witten prevented adcomm members from voting on Covis’ proposal to restrict the preterm birth prevention drug's indication while further study was conducted, company says.
End Of An Accelerated Approval Odyssey: Covis Agrees To Withdraw Makena But Seeks 21-Week ‘Wind-Down’
Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.
The Risk-Reward Of US FDA Leadership Running Offices Below Them
CBER’s Celia Witten is the latest senior executive to run an office within the center during a leadership transition, a move that can help achieve specific goals, but also create tension.
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