FDA To Analyzee Its Drug Safety Procedures
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Dr. Lester Crawford, acting FDA commissioner, authorized the Center for Drug Evaluation and Research (CDER) to sponsor the Institute of Medicine (IOM) to study the drug safety system with emphasis on the post-market phase.
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The report is likely to intensify a debate about the safety of the nationÂs drug supply and the adequacy of government oversight.
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LEADING medical journal editors and lawmakers have rightfully focused a spotlight on how well the Food and Drug Administration monitors the safety of drugs after they are approved.
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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 steps to improve the safety of medications.
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The Food and Drug Administration 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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NEW YORK, December 24  - The Food &amp; Drug Administration (FDA) announced yesterday that it planned to examine the various studies that link the usage of several painkillers with heightened cardiovascular risks, while recommending that
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The US Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.&#39;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 (news - web sites) on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck &amp; Co.
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Startling testimony by an FDA drug safety reviewer about five popular medications has the medical world buzzing about how tightly the agency should be regulating new medications.
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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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The Bush administration and some of its critics squared off yesterday over whether the Food and Drug Administration (FDA) is doing an adequate job overseeing drug safety, and whether the agency needs major reforms.
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc and Schering-Plough's cholesterol medicine Vytorin  following the drug's failure to work better than a generic drug  in a study of plaque build-up in neck arteries.
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The public should have reasonable expectations that medicines the Food and Drug Administration has approved for the market are, in fact, safe.
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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 U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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Washington --- The Food and Drug Administration, accused in recent weeks of being cozy with the pharmaceutical industry, must open its practices to greater public scrutiny, says a top official of the agency&#39;s besieged Office of New Drugs.
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The U.S. Food and Drug Administration said on Tuesday it would make organizational changes to improve internal communication about potential risks that emerge after a new drug reaches the market.