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

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...

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