FDA 483 - University of Arkansas for Medical Sciences IRB - September 29, 2017

An FDA inspection of the University of Arkansas for Medical Sciences IRB identified a significant issue where clinical investigators failed to report the emergency use of test articles to the Institutional Review Board. Specifically, multiple instances were found where emergency use notifications were not submitted within the required timeframe, with one case having no notification submitted to date. This indicates a breakdown in timely reporting procedures for emergency uses of unreviewed test articles.