Seven Days In March: NDA-BLA and ANDA Approval Output Diverged As Coronavirus Teleworking Began
New drug approvals dropped, likely because of a new focus on COVID-19 treatments, while generic drug approvals increased.
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Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.
Productivity remains high as full ANDA approvals reached a FY 2020 peak and complete responses dropped to another low in June.
The pandemic's impact was mentioned only in FDA's calculations for fees including those established by PDUFA. In addition to prescription drug applications, PDUFA fees are charged for OTC switch applications and other proposals for ingredients that are not part of an OTC monograph to be made available nonprescription.