‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively
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.
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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.
The ideas could potentially address sponsor concerns about the effects of slow reviews.
Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.