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US FDA’s Use Of CRLs Hit A High Note In 2022: One-Third Of Novel Agent Decisions Were Not Approvals

 
• By Bridget Silverman

Pink Sheet infographic details the 20 complete response letters the US FDA issued for novel agents last year.

FDA says talk to the hand
• Source: Shutterstock

The number of US FDA complete response letters known to have been issued for novel agents in 2022 inched up from 2021 – from 18 to 20, according to the Pink Sheet FDA Performance Tracker’s Complete Response Letters chart – but the drop off in novel approvals in 2022 gave the CRL its biggest workout in years: 31% of the agency’s decisions on novel agents resulted in a CRL.

With 2021’s high novel approval count of 60 agents across both FDA’s drug and biologics centers, CRLs only made up 23% of last year’s novel agent actions, but that proportion...

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