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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COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.
With a virtual visit to SciVac in Israel, a belated Revance site inspection in California and two weeks at a Dr. Reddy’s site in India, the US FDA finds ways to overcome travel restrictions in its efforts to oversee drug manufacturing quality.
US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.