FDA of Failing To Act on Information About Link Between ...
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FDA could make a decision within days on whether to adopt an advisory panel&#39;s recommendations to include a black box warning about the increased risk of suicidal tendencies that antidepressants pose for children, and any labeling changes could be
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A previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released today by the Union of Concerned
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The U.S. Food and Drug Administration denied charges it tried to suppress a safety official's findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
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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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About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency&#39;s monitoring of the safety of prescription
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An unsurprising response from the FDA.
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The Food and Drug Administration said yesterday that it does not plan to follow the lead of Canadian regulators who took a drug for attention-deficit hyperactivity disorder off the market because of reports that it has been linked to 20 sudden deaths and a dozen strokes, including some among children.
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Washington - An expert with the United States Food and Drug Administration (FDA) has said on Thursday he was pressured by his agency to stifle study results showing the potential dangers of the anti-inflammatory drug Vioxx.
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A federal advisory panel voted unanimously yesterday that the first drug to enhance the sex drive of women should not be approved because of a lack of information about its long-term safety.
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The Food and Drug Administration is considering not using the word "recall" to warn patients and doctors about defective pacemakers and defibrillators at the request of a physicians' group struggling to deal with a loss of public confidence in the safety of implantable heart devices.
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The US Food and Drug Administration yesterday sought to distance itself from remarks by one of its top safety officials that raised concerns about key drugs made by Astrazeneca and Glaxo Smithkline.
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There was a puzzling line in a report in which the Bush Administration asserted it could not vouch for the safety of foreign, lower-cost prescription drugs.
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The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival
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&quot;We were wrong about Vioxx, but you can trust us on all those other meds,&quot; the FDA seems to be saying. If you enjoy this article, you may also be interested in an article entitled &#39;The FDA remains in state of denial about drug safety questions.
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The safety of Merck&#39;s (MRK:NYSE - news - research) Vioxx has been questioned again with the posting of an internal Food and Drug Administration study on the agency&#39;s website.
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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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A Food and Drug Administration official warned Congress yesterday that the FDA would be unable to prevent another episode like the Vioxx case, in which the popular arthritis