FDA to Review Post-Market Safety Checks
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration will ask the Institute of Medicine to study the  agency's safety monitoring of medicines already on the market,  Acting FDA Commissioner Lester Crawford said on Friday.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc  and Schering-Plough's  cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.
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With the stunning recall of a popular pain medication last week and the impact it had on patients, the stock market and its manufacturer, it may be worthwhile to review how drugs get to market and how safety data are gathered.
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Congress ought to write a detailed prescription for change in US oversight of drug safety. The public deserves better protection from potentially dangerous new medicines.
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Regulators said on Friday they were reviewing the safety of Allergan Inc's  Botox and a competing product after reports of deaths and serious reactions in some patients.
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After two highly publicized incidents questioning the safety of some of the biggest selling prescription medicines, the Food and Drug Administration said yesterday it is moving to strengthen its safety monitoring efforts.
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The US Food and Drug Administration is supposed to be a vigilant industry watchdog that prevents harmful products from reaching America&#39;s kitchen tables and medicine chests.
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U.S. regulators said on Friday they were reviewing the safety of Allergan Inc's Botox and a competing product, after reports of deaths and serious reactions in some patients.
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The US Food and Drug Administration, facing a barrage of criticism from both within and outside the agency, announced plans Friday to improve the safety of drugs after they have been approved.
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The U.S. Food and Drug Administration will announce on Tuesday it will create an independent drug safety oversight board as a new measure to strengthen the safety of drugs already in the marketplace, an administration official said.
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The Food and Drug Administration said yesterday it will create an independent drug safety board -- as critics have demanded -- that would quickly direct the agency how to respond to drugs on the market that are suspected to be unsafe.
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The U.S. Food and Drug Administration expects to inspect Boston Scientific Corp.'s Galway, Ireland factory in the "near future" as part of its probe into the company's coronary stent recall, the Wall Street Journal said on Friday.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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The FDA will review its new cholesterol drug.
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WASHINGTON The Food and Drug Administration has ordered a sweeping review of studies involving prescription painkillers like Celebrex and Bextra.
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The Food and Drug Administration  said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.