FDA to Review Post-Market Safety Checks
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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review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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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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The U.S. Food and Drug Administration has targeted five regions around the world where it would like to establish a greater presence to monitor the safety of exported food, drugs and other goods, the top FDA official said on Thursday.
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Drugs in the same category as Merck &amp; Co. Inc.&#39;s withdrawn Vioxx painkiller will get close scrutiny to see if they can also cause heart attacks, US Food and Drug Administration officials said on Thursday.
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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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Dr. Steven Galson, acting director of the Food and Drug Administration&#39;s Center for Drug Evaluation, announced Friday that the FDA will review five popular drugs whose safety is being questioned.
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WASHINGTON The Food and Drug Administration is vowing to appoint a director of drug safety and take other steps to ensure the safety of medications.
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LOS ANGELES -- The Food and Drug Administration said Wednesday it is checking whether shipments of Chinese seafood on an agency watch list were properly cleared for public consumption without being tested for banned drugs or chemicals.
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The Food and Drug Administration said last night it would convene a public panel to examine the risk of blood clots in patients with drug-coated stents, among the world's most frequently implanted medical devices.
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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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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
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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.
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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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Medicines watchdogs are reviewing safety data for an entire class of drugs taken by millions of patients with arthritis and severe pain after the worldwide withdrawal of Merck&#39;s Vioxx last week.
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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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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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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.