Happy New Year, Generics: Early FY 2015 Data Show FDA Getting Handle On ANDAs
Approvals increased and submissions decreased through first two months of fiscal year 2015 compared to same period in FY 2014.
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First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.