US FDA’s Breakneck Approval Pace Clashes With Advisory Committee Mandate

 
• By Michael McCaughan

FDA has approved more than 100 novel molecules in the past two years, almost all of them without an advisory committee stop. Is it time to revisit a 2007 law that was intended to assure a public vetting of NMEs prior to approval?

Skip AdComs
US FDA has been pressing the "Skip AdComs" button on its drug reviews, leading to faster approvals for sponsors, but fewer opportunities to comment for outside stakeholders. • Source: Photo illustration by Jean Marie Smith

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