FDA Censures Glaxo Over Flawed Avandia Reports

Law360, New York (April 9, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has issued a warning letter to GlaxoSmithKline Plc for repeatedly failing to report clinical trials related to its diabetes drug Avandia, which has been tied to heart attacks in consumers.

The letter to GSK CEO Jean-Pierre Garnier, dated March 25, said the company's numerous failures to provide complete mandatory reports violated federal laws and ordered GSK to take actions to prevent further omissions.

The FDA discovered the omissions in the fall, while inspecting whether GSK corporate headquarters complied with post-marketing...
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