The cost of conducting a clinical study has increased over the years, and thus, this rapid increase has led to companies’ growing interest in cost-saving strategies. That being said, I agree with neb2 because manufacturers of medical products have pursued a number of options to reduce cost, including the use of data from sites outside of the US. Depending on the site and the cost of care in the specific location, a clinical study conducted outside of the US can result in possibly in savings of approximately 50% or more. Additionally, the use of outside clinical data to support FDA submissions can save a company time. For example, in the US, some studies that present a large risk to human subjects require prior FDA approval and IRB approval. For products that obtain CE marking prior to FDA approval, the process of starting post-CE mark studies would certainly be a faster process than obtaining IRB approval or other US pre-clinical approvals. As other students mentioned below, there are many other factors to also consider before deciding whether to use foreign clinical data to support FDA submission.