Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals
Executive Summary
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
You may also be interested in...
ANDA Approval Decline Continues, But Why?
US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.
ANDA Approval Decline Continues, But Why?
US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.
Pandemic Effect: Sponsors Paid Far Fewer User Fees Than Expected In FY 2020
Revenue increases are expected in FY 2021 over pre-pandemic estimates, in part because the US FDA believes sponsors may have applications that were delayed by COVID-19.