Trade groups representing the pharmaceutical and clinical research industries endorsed the US Food and Drug Administration’s (FDA) approach for conducting remote interactive evaluations (RIE) as an alternative inspection tool but want more clarity on what FDA will provide at close-out meetings.
Industry groups also want clarity on when the agency will request a RIE instead of conducting an on-site preapproval (PAI) or prelicense inspection (PLIs). There were also calls to consolidate various guidance documents on remote inspections into one document.
The guidance, which was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), covers PAIs, PLIs, postapproval inspections, surveillance inspections, follow-up and compliance inspections, as well as bioresearch monitoring (BIMO) inspections…
