Draft guidance from the US Food and Drug Administration (FDA) outlines the agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics facilities in lieu of onsite inspections and how industry can prepare for these inspections. The draft guideline was issued on 25 October.
The agency wants to continue using this auditing mode following its “successful use” during the COVID-19 pandemic. The guidance was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
The guidance covers preapproval inspections, prelicense inspections, postapproval inspections, surveillance inspections, follow-up and compliance inspections, and bioresearch monitoring (BIMO) inspections. It replaces an earlier version issued in April 2021 (RELATED: FDA issues long-awaited pandemic remote inspections guidance, Regulatory Focus 14 April 2021)…
