Topic: Food and Drug Administration

FDA bars new patients from enrolling in safety study of diabetes drug tied to heart risksFederal health officials say new patients should not be enrolled in a study of GlaxoSmithKline's controversial diabetes pill Avandia, after experts last week said the drug increases ...

FDA warns Abbott on blood sugar monitors

CHICAGO (Reuters) - The U.S. Food and Drug Administration has warned Abbott Laboratories' diabetes care unit about manufacturing problems at its Alameda, California plant, a letter released Tuesday said. In a letter dated July 2, FDA said its inspectors found Abbott's Freestyle ...

Experts urge US to restrict drug Avandia

A majority of members of a key advisory committee recommended that the US government allow diabetes drug Avandia to stay on the market with greater restrictions on its sale. Most of the panel's members agreed that the drug increases the risk of ...
Diabetes drug Avandia faces a moment of truth Wednesday, when a committee will decide whether to recommend pulling it from the market because it has been associated with increased heart problems. The committee, convened at the request of the Food and Drug ...
British pharmaceutical giant GlaxoSmithKline hid the dangers of its top-selling diabetes drug Avandia and secretly wrote scientific articles about it, two US lawmakers charged Tuesday. The allegations came as the Food and Drug Administration (FDA) opened a two-day meeting of experts who ...
UK pharmaceutical giant GlaxoSmithKline kept the dangers of its top-selling diabetes drug Avandia out of the public eye and ghostwrote scientific articles about it, US lawmakers charged Tuesday. The allegations came as the Food and Drug Administration (FDA) opened a two-day meeting ...
British pharmaceutical giant GlaxoSmithKline withheld from US drug safety regulators information about the possible dangers of top-selling diabetes drug Avandia, a report in the US press said Tuesday. The allegation was made in the Wall Street Journal on the day that Food ...
British pharmaceutical giant GlaxoSmithKline withheld from US drug safety regulators information about the possible dangers of top-selling diabetes drug Avandia, a report in the US press said Tuesday. The allegation was made in the Wall Street Journal on the day that Food ...

U.S. meeting nears on risks of Glaxo diabetes drug

WASHINGTON (Reuters) - A heated three-year safety debate about a GlaxoSmithKline Plc diabetes pill reaches a climax this week as opponents and backers face off at a U.S. meeting that will help decide the drug's fate. A panel of scientific experts meets ...
GlaxoSmithKline's blockbuster diabetes treatment Avandia suffered a new setback Friday when US health officials offered more evidence of the drug's increased link to heart problems. A document released by the Food and Drug Administration came as an FDA panel of experts prepares ...
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