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End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes

 
• By Bridget Silverman

Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

• Source: Shutterstock

The US FDA Center for Drug Evaluation and Research’s novel approvals class of 2022 is notable for the absence of very fast reviews – approvals that come within six months of submission, or at least two months in advance of a priority review goal date – marking another way in which the year 2022 reversed course from the agency’s recent past.

Approvals well in advance of the user fee goal date had become almost commonplace during the novel approvals boom. Between...

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