The OIG has released a report entitled “Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials.” The purpose of the report is to assess the volume of data submitted to FDA from clinical trials conducted in foreign countries, and to evaluate the extent to which FDA monitors and inspects foreign clinical trials. The report found that 80% of approved marketing applications for drugs and biologics contained data from foreign clinical trials, and the majority of clinical trial subjects and sites were located in foreign countries. The OIG reported that FDA inspected clinical investigators at less than 1% of foreign sites. The report noted that, in the absence of an investigational new drug application (IND), FDA has no mechanism for becoming aware of foreign trials; thus, it cannot effectively monitor them. The report recommends that FDA: (1) require standardized electronic clinical trial data; (2) create an internal database of clinical trial data; (3) monitor trends in foreign clinical trials not conducted under INDs; and (4) if necessary, take steps to encourage sponsors to file INDs.