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The Long And Short Of Accelerated Approval Accountability In US

 
• By Michael McCaughan

The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.

fast and slow
FDA appears to be accelerating the pace of withdrawing products with missing or failed confirmatory studies. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Food & Drug Administration’s efforts to reinforce the credibility of accelerated approval confirmatory trial requirements should be helped by a series of announcements in November.

You might even call it the long and short of accountability for sponsors in the program.

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