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 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 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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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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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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Congress ought to write a detailed prescription for change in US oversight of drug safety. The public deserves better protection from potentially dangerous new medicines.
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The Food and Drug Administration will establish a new independent Drug Safety Oversight Board to monitor FDA-approved medicines once they're on the market and update physicians and patients with emerging information on risks and benefits.
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The Food and Drug Administration  will announce on Tuesday it will create an independent drug  safety oversight board as a new measure to strengthen the  safety of drugs already in the marketplace, an administration  official said.
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The U.S. Food and Drug Administration will announce on Tuesday it will create an independent drug safety oversight board as a new measure to strengthen the safety of drugs already in the marketplace, an administration official said.
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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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The U.S. Food and Drug  Administration will announce on Tuesday it will create an  independent drug safety oversight board as a new measure to  strengthen the safety of drugs already in the marketplace, an  administration official said.
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The Food and Drug Administration  said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.
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ROCKVILLE, Md.  - 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 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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Taking a look at how drug approval rates have fared under different FDA commissioners.
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The Consumers Union is calling on the Food and Drug Administration (FDA) to implement measures to improve prescription drug safety and transparency.
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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.