1. Pink Sheet

US FDA Advisory Committees: Flipping FDAAA Mandate On Its Head

 
• By Michael McCaughan

FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?

FDA advisory committee drought
FDA's Great Room has been a little desolate of late. • Source: Nielsen Hobbs; the Pink Sheet | Alamy images

The ongoing COVID pandemic is having an impact on all aspects of the US Food & Drug Administration’s operations, but (apart from inspections) the effects may be most dramatic in the agency’s use of public advisory committees.

The disruptions and logistical complications for “virtual” advisory committee meetings are no doubt contributing to record-low numbers of review. In...

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