FDA Passes New Rule On Foreign Drug Trials

Law360, New York (April 28, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration will adopt new rules for foreign clinical studies used in drug approval applications, including adherence to standards of good clinical practice and approval by an independent ethics committee, the agency said Monday.

The new rule, set to take effect on Oct. 28, will replace the FDA's current requirement that foreign clinical studies conform to the Declaration of Helsinki, an international agreement on clinical trials signed in 1989.

The rule applies to clinical studies not conducted under the FDA's usual procedure...
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