FDA wants drug safety 'report cards'
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The public outcry over the withdrawal of the painkiller Vioxx is leading to closer government scrutiny of new drugs to identify and disclose late-developing safety problems.
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WASHINGTON - A new Food and Drug Administration analysis backs earlier suggestions of a link between at least some antidepressants used by children and suicidal tendencies, prompting the agency to prepare new warnings.    Exactly what those warnings will say, and which drugs will be affected, hasn't been settled, according to FDA documents released Friday...
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A document released by the FDA outlines its concerns with GPC's lead drug.
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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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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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The U.S. Food and Drug Administration said on Tuesday it was creating a new drug safety board to improve the monitoring of medicines already in the marketplace, a response to charges the agency has failed to protect the public from dangerous side effects.
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A Food and Drug Administration  reviewer who has criticized the agency for being lax in  monitoring drug safety said on Thursday five medicines on the  market need close scrutiny for possible side effects.
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The U.S. Food and Drug   Administration needs more staff, funding and power over the   drug industry to better police the safety of medicines after   they reach the market, an Institute of Medicine panel said on   Friday.
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WASHINGTON Nov 5, 2004 - Buffeted by criticism, the Food and Drug Administration said Friday that it would appoint a director of drug safety and take other actions to assure the safety of medications it approves.
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Consumer Reports' effort to rate drugs offers a lesson to pharmaceutical companies.
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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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Britain is to overhaul and open up its drug safety monitoring system, already viewed as one of the better schemes worldwide, in the wake of recent scandals over the side effects of some medicines. Patients will in future be able to view anonymous data on suspected adverse drug reactions on the Medicines and Healthcare Products Regulatory Agency's (MHRA) Web site, Health Minister Lord Warner said Monday.
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The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children
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The US Food and Drug Administration, under sharp criticism for its drug safety behavior involving anti-inflammatory drugs, antidepressants, and the silencing of its own drug safety scientists, has been offered a new name today: the Fraud and Drug
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Medical researchers said the U.S. needs a system independent of the F.D.A. to detect harmful effects of drugs already on the market.
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Merck &amp; Co.&#39;s recall of the Vioxx painkiller shows why the US Food and Drug Administration needs its safety monitors to be independent of those who approve new medicines, FDA scientist David J. Graham told a Senate hearing.
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The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.