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

 
• By Sue Sutter

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.

Man shouting
FDA needs to be more forceful in messaging about accelerated approval drugs on the verge of withdrawal. • Source: Shutterstock

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