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...
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