Most FDA decisions still on time

Despite a few notable delays, FDA is still completing most reviews on or just before the PDUFA date. Since April, the median timing for a decision was one day before the slated decision day, though the range stretched from 51 days early to 45 days late.

In April, the PDUFA date for Nuvaxovid from Novavax Inc. NASDAQ:NVAX) passed without a decision amid politicization of COVID-19 vaccines, with eventual approval 45 days later. ...