Preparing For The Return Of US FDA Inspections
FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.
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US agency mostly saw less of the same when it scaled back inspectional activity during COVID-19, but observed more training and equipment issues.
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.
With more experience, the US FDA was able to standardize record review requests and timing.