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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Acting OGD Director Susan Rosencrance says in an interview that the generics assessment system has evolved substantially since she moved to the Office of Pharmaceutical Quality in 2015.
Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.
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.