‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively
Executive Summary
ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.
You may also be interested in...
GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.
GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.
COVID-19 Supplement Approvals Jump, Some On-Time Decision Rates Slip For US FDA
In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.