US FDA Cautions Against Blaming CRLs On Inspection Delays
Agency revises pandemic inspection guidance to explain CRL ‘non-deficiency’ inspection comments and update industry on remote interactive evaluations and post-COVID-19 inspection priorities.
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Agency inspectors worked in the country for about a month before the coronavirus infection surge forced another halt.
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.