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.

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.

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.

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.