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.

Packaging for such products reflects ‘unique circumstances’ that should exempt them from the rebates on discarded drugs otherwise required by the policy, stakeholders tell CMS at a ‘town hall’ forum.

Medtech Insight was invited to ask questions at a roundtable event organized by Russo Partners to review the major medtech industry trends of 2022 and what to expect in 2023.

In the second part of Generics Bulletin’s exclusive interview with Fresenius Kabi’s senior vice president for biosimilars in the US, Ali Ahmed, he explains why Kabi is relishing the prospect of competing in pegfilgrastim and what the acquisition of mAbxience means for the company’s prospects and vision.