FDA's Inspections of US and Non-US Clinical Studies

Abstract

The Food and Drug Administration (FDA) is currently conducting approximately 250 inspections a year in the United States and ten inspections a year in foreign countries. The Routine Inspections are data oriented (ie, aimed at the validation of clinical data) and are conducted only in the United States. The For Cause Inspections (FCIs) are either data oriented or investigator oriented and are conducted in the United States and in foreign countries. In approximately 10% of the routine inspections, the study deficiencies have been serious enough to warrant follow-up FCIs. The FCIs have resulted in administrative action in 98 cases and criminal prosecution in 16 cases. Of the 42 pivotal foreign studies evaluated by an FDA on-site inspection, 43% (ie, 18 of 42) have been judged not usable in support of drug claims