‘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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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.
Biocon awaits site inspection after pandemic-amplified delays keep its Viatris-partnered bevacizumab out of the US market, though the Indian company believes they can still make good and garner market share. All eyes are also on traction for their insulin glargine via increased share of formulary contracts.