The US Food and Drug Administration missed its on-time generic drug application action commitment during the second fiscal quarter, but the agency expects to be able to use a relatively new accounting technique to get the number officially above water once a few pending applications are adjudicated.
‘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.
