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Latest From Covis Pharma

US FDA Urged To Improve Messaging To Professional Societies On Accelerated Approval Withdrawals

Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.

Review Pathway Post Market Regulation & Studies

Inside US FDA’s Return To In-Person Meetings

In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.

Advisory Committees Coronavirus COVID-19

FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’s Advice

In a memo to Commissioner Califf and Chief Scientist Bumpus, Celia Witten focuses the final Makena decisionmakers on the key factors she believes should be used to determine the drug’s market status.

Post Market Regulation & Studies Drug Approval Standards

Makena’s Reimbursement Coverage Remained Unchanged After Confirmatory Trial Failure

As milestone approaches in FDA effort to pull the pre-term birth drug, the findings suggest that by leaving Makena on the market, the agency may be ‘furthering plan inaction,’ Tufts Medical Center researchers conclude.

Reimbursement Review Pathway
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