Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach

With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.

two couple are showing half full and half empty side of water glass with their fingers — Will second-half approvals fill US FDA's glass to record-breaking levels?

In a world without COVID-19, the US Food and Drug Administration would be in position to shatter records for novel approvals (again) in 2020, with a 10-year best tally for the first six months of the year and a second half loaded with user fee goal dates for almost 40 new molecular entities and novel biologics.

In the world with COVID-19, the complete response letter rate for those pending NDAs and BLAs could be higher than...