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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

The US Food and Drug Administration should be more forceful in its communications to professional societies about accelerated approval drugs which have failed to confirm clinical benefit and for which withdrawal is being proposed.

The sometimes lengthy interval between the agency’s proposal to pull a drug’s marketing approval and the actual withdrawal creates an...

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