ANDA Approval Decline Continues, But Why?
US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.
You may also be interested in...
Final commitment letter preparations now under way as revenue issues are resolved.
Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.
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.