Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
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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.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.
US FDA will determine on a case-by-case basis whether its inability to inspect a facility because of the pandemic could result in 180-day exclusivity forfeiture for first generic filers.