FDA's Tightening Rein Over Foreign Clinical Trials

Law360, New York (May 4, 2012, 1:40 PM EDT) -- Over the last decade, drug, device and biotechnology companies have taken their demand for clinical trial work to the global marketplace, vastly increasing the number of trials taking place outside of the United States.

In 2008, for instance, 80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials, and more than half of all clinical trial subjects and sites were located outside the U.S.[1]

While usage of foreign clinical trials to support drug and biologic marketing applications continues to increase,...
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