FDA Presses Domestic Manufacturers To Engage In Remote Regulatory Assessments In Lieu Of Inspections

A US FDA official says the agency’s taking steps to plan for post-pandemic on-site inspections that could look slightly different than typical agency audits pre-COVID-19. But in the interim, some companies are being asked to participate in voluntary Remote Regulatory Assessments.

Two people meet virtually.

A US Food and Drug Administration official says the agency is taking steps to plan for post-pandemic on-site inspections that could look slightly different than typical FDA audits that took place before anyone even heard of COVID-19.

But in the interim, domestic companies may be asked to participate in voluntary Remote Regulatory Assessments (RRAs).

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