1. Pink Sheet

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

It is hard to find fault with the US Food & Drug Administration’s performance when it comes to new drug approvals.

The agency cleared 48 new molecular entities in 2019, a number that would be jaw-dropping but for the fact that 59 NMEs were approved in 2018. The final tally may not have been as high, but FDA still showed some record-breaking spirit with a high number of ahead-of-deadline approvals during the year

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