Using Alternative Tools, US FDA Avoided Half Of ANDA Pre-Approval Inspections During Pandemic
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.
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ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.
As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.