FDA Bars New Patients From Avandia Study

Law360, New York (July 21, 2010, 4:38 PM EDT) -- The U.S. Food and Drug Administration is blocking new patients from taking part in a safety trial of GlaxoSmithKline PLC’s diabetes treatment Avandia as regulators decide whether to keep the drug on the market.

The agency said Wednesday it had placed a “partial clinical hold” on the postmarketing trial and directed the drugmaker to update investigators, review boards and ethical committees involved in the study on safety concerns of Avandia raised at an FDA advisory committee meeting on July 14.

Patients already enrolled in the study...
To view the full article, register now.