Legal Updates
FDA Urges Additional Testing for Diabetes Drugs
Wednesday, July 02, 2008
On July 2, 2008 an FDA panel suggested that diabetes drugs should face stricter standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. FDA advisers voted 14-2 on July 2, 2008 that all new diabetes drugs must undergo longer studies to…
Avandia Manufacturer Failed to Provide Data
Tuesday, April 08, 2008
On April 8, 2008, the FDA publicized in a warning to GlaxoSmithKline that the company was unsuccessful in reporting all of the required post-approval data on its widely prescribed diabetes drug Avandia. A strong warning about heart attack risk was added to the label of Avandia in November 2007, and…
Diabetes Study Halted After Deaths
Wednesday, February 06, 2008
The National Institute of Health was forced to shut down a portion of a major study on heart disease and diabetes after an unforeseen number of deaths amongst patients receiving intense therapy to decrease their blood sugar. The therapy was aimed at reducing to normal levels the blood sugar of…
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