The U.S. Food and Drug Administration has sent Johnson & Johnson a letter warning that it has been improperly marketing two of its products, TruMatch Personalized Solutions Systems and the Corail hip System. The FDA has ordered the company to stop marketing the products for certain uses until they are awarded approvals.The letter stated...
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Category: Pharmaceutical
GLAXO’s SECRET AVANDIA DOCUMENTS? FDA DIGGING (AGAIN)
THE FDA has confirmed that it is reviewing documents from Glaxo to see whether damaging information about heart attacks caused by its Diabetes drug might have been hidden from the agency. FDA reviewer Robert Misbin, an expert on Diabetes drugs spotted an analysis back in 2006 on Avandia done by an FDA statistician which...
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FDA Avandia Fight-Testing Ground For Drug Evals
The FDA's decision yesterday to keep GlaxoSmithKline's Diabetes drug Avandia on the market, may be just an early battle in a long war as we appear to be at a new point in defining FDA powers and the standards for drug testing. So far, regulators have been reluctant to pull a major drug off...
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FDA Experts Vote to Keep Avandia on the Market with new warnings
20 of 33 outside scientists assisting the FDA in assessing the Diabetes drug voted to keep Avandia,, on the market with new warnings about the risks of heart attacks and strokes. Two recent studies, one at The Cleveland Clinic and one at the FDA recommended withdrawal of the drug from the market. The numbers...
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FDA LIKELY TO YANK AVANDIA-GLAXO TO SETTLE FOR $460 MILLION
The FDA is holding special meeting to review the evidence on the GlaxoSmithKline diabetes drug Avandia. Word is the drug may well be removed from the market based on the reports of FDA staffers including THIS REPORT. Meanwhile, shares of GlaxoSmithKline (GSK) are up 76 cents, or 2.2%, at $35.88, a sudden...
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FDA holding critical Avandia hearings tomorrow and Wednesday
Drug and biotech companies will be closely watching the upcoming two day advisory committee meeting tomorrow and Wednesday to review the safety of GlaxoSmithKline's Avandia diabetes drug. At issue is not just this drug's safety but the FDA's new methodology and philosophy in handling its analysis of drug safety. Also under scrutiny is whether...
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Avandia: FDA where are you?
Despite various studies and congressional testimony of experts revealing the risks of heart attack and stroke from the Diabetes drug Avandia, the company is still selling the product and the FDA has not convened to decide on removing it from the market. The real question is why has there been such a delay, given...
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2 STUDIES: AVANDIA UNSAFE POSE HEART ATTACK AND STROKE RISK
Two major studies released Monday say that the diabetes drug Avandia is unsafe causing increased risk for heart attack and stroke. One of the studies was conducted by an FDA physician and the other by the Cleveland Clinic. A vote at the FDA is expected soon as to whether to order it off the...
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Heart/Stroke Risk of Diabetes Drug Avandia known for years
Two major studies released this week, one from the FDA and one from the Cleveland Clinic revealing significant dangers of stroke and heart attack risks of the Type-2 Diabetes drug Avandia were not the first studies to reveal these dangers. In fact a Senate report regarding other studies released in 2007 said that the...
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DRUG COMPANIES TARGET ONLNE SOCIAL MEDIA ADS FOR BIG $$
Instead of patients going to their physicians saying they saw a drug advertised on TV, this will switch to "I saw it on Youtube". Several drug companies have launched Youtube ad campaigns promoting drugs with patient testimonials. In addition, this is spreading to Twitter and Facebook. Online media is far less expensive and probably...
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