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News Tip

FDA Issues Final Ruling on Foreign Clinical Trials

June 19, 2008

The U.S. Food and Drug Administration has issued a final ruling regarding clinical trials held in foreign countries. Effective Oct. 27, requirements will be standardized across the U.S., while new requirements will be added for trials in many countries. As a result, to sell drugs tested in foreign trials in the United States, pharmaceutical companies will need the help of lawyers to design the trials to meet U.S. standards.

A number of questions remain as to how the provisions will be applied and enforced by the FDA.