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US FDA Picks Up The Pace Of Complete Response Letters Over June And July

 
• By Bridget Silverman

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

'COMPLETED' red word as rubber stamp

The US Food and Drug Administration has issued far fewer complete response letters in 2020 than in the past several years, but a recent burst of actions could suggest a change is coming. Of the 11 CRLs announced in 2020, a majority – seven letters – have come since the middle of June.

Between 2016 and 2019, the agency averaged 36 complete response letters (CRL) annually, according to data from the Pink Sheet’s US FDA

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