U.S. report faults FDA oversight of drug trials
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A report to be released on Friday finds the U.S. Food and Drug Administration does very little to ensure the safety of patients who help test drugs in clinical trials, The New York Times reports.
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A scientist working at the US Food and Drug Administration accuses the agency of "profound failure" in its oversight of the recently withdrawn arthritis drug Vioxx.
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The US 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 &amp; Co.
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U.S. regulators said on Friday they  would review a study showing a Merck and Schering-Plough  cholesterol drug worked no better than a generic in preventing  the build-up of arterial plaque.
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Importing cheaper prescription drugs should not come at the expense of safety, said a US government report issued on Tuesday that highlighted the problems of ensuring the medicines are equivalent to those in the United States.
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A document released by the FDA outlines its concerns with GPC's lead drug.
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The Food and Drug Administration is responding to the widespread criticism of the government's handling of drug safety problems.
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NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.
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U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc's and Schering-Plough Corp's popular cholesterol drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.
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U.S. regulators said on Friday they  would review whether to take action over Merck & Co Inc's   and Schering-Plough Corp's  popular cholesterol  medicine Vytorin after a study showed it was no better than a  generic drug in preventing the build-up of fatty plaque.
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Description: A Bush Administration task force releases a report that finds importing drugs from countries with price-controls offers little savings and introduces safety concerns.
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Nov. 19, 2004 -- New allegations from an FDA scientist that the agency is failing at its job of ensuring the safety of the drugs it approves has many Americans thinking twice before taking their daily dose.
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the US federal Food and Drug Administration to protect Americans from such risks.
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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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Taking a look at how drug approval rates have fared under different FDA commissioners.
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A drug safety reviewer said the FDA is "incapable of protecting" the public and urged the government to review five new drugs for safety issues.
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BITTER PILL: Federal officials say research was flawed in two major studies showing oral contraceptives cut the risk of heart disease and carried no increased risk of breast cancer &#151; results contrary to many previous findings.