FDA to recheck safety of drug trials
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The Food and Drug Administration yesterday called for an evaluation of all prevention studies involving two controversial painkillers - Celebrex and Bextra - to ensure adequate protection for participants who use the pills.
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The U.S. Food and Drug  Administration on Thursday ordered the review of preventative  studies involving Pfizer Inc.'s painkillers Celebrex and  Bextra, in light of recent evidence they may increase the risk  of heart attack and stroke.
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The US Food and Drug Administration is pushing for an expanded review of MDS Pharma&#39;s generic drug studies at its Montreal laboratories, and has requested a meeting with the company to discuss its concerns.
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The global pharmaceutical industry  unveiled plans on Thursday to publish more data about trials of  medicines in a bid to reassure patients following recent alarms  over drug safety.
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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 problems with Vioxx, taken off the market last week, raise questions about the Food and Drug Administration's safety review process. Observers say longer clinical trials should be required.
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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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WASHINGTON/NEW YORK  - A U.S. Food and Drug  Administration reviewer who has accused the agency of being lax  in monitoring drug safety on Thursday said five medicines on  the market need closer scrutiny.
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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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Drug stocks took another hit Friday, a day after a veteran Food and Drug Administration researcher said that five drugs currently on the market needed closer scrutiny for possible safety risks.
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An internal survey of Food and Drug Administration scientists conducted by the Health and Human Services Office of the Inspector General revealed safety concerns about the FDAâs approval process and monitoring of marketed drugs, according to a press
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WASHINGTON - The Food and Drug Administration (news - web sites) will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
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The U.S. Food and Drug Administration  said on Friday that Senate testimony by a veteran FDA  researcher regarding safety risks for five drugs does not  reflect the views of the agency.
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The Food and Drug Administration announced it would hire the government's top scientific review agency to figure out whether its drug-safety system is adequate.
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Two-thirds of Food and Drug Administration scientists surveyed two years ago lacked confidence that the FDA adequately monitors the safety of prescription drugs, a report released Thursday shows.
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A veteran scientist at the Food and Drug Administration said yesterday he will present new, unpublished findings about heart risk associated with a number of pain drugs at a meeting to assess whether they are safe enough for patients.
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The global pharmaceutical industry unveiled plans on Thursday to publish more data about trials of medicines in a bid to reassure patients following recent alarms over drug safety.