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US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters

 
• By Bridget Silverman

COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

FDA Complete response stamp holder
US FDA has been using its "complete response" stamp more frequently. • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

The year 2022 has seen a dramatic escalation in the rate of complete response letters to approvals of novel agents, even against the backdrop of increasing CRL numbers in the past several years, a Pink Sheet analysis of our US FDA Performance Tracker data shows.

Almost half – 47.1% – of the novel agent applications acted on by the FDA in 2022 have received CRLs:...

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