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

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...