Idea of Drug Safety Office Is Already Hitting Snags
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Despite calls from medical experts and a prominent Republican senator for an independent office to monitor drug safety, the idea, prompted by the Food and Drug
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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.
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Arguing that the country&#39;s system for monitoring drug safety is haphazard and ineffectual, editors of a leading medical journal Monday called for a radical overhaul and suggested the creation of a new independent drug safety board.
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Research and development costs drag down the drug developer's bottom line.
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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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Authorities and pet owners are beginning to raise serious questions about the safety and effectiveness of animal medicines, mirroring worries over human drugs like the painkiller Vioxx.
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Because of PfizerÂs failed trial, drugs similar to torcetrapib from other companies could face greater scrutiny Â and delays Â in getting to market.
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Two years after the withdrawal of the painkiller Vioxx, federal health regulators still lack the resources necessary to track the safety of new drugs and respond quickly to any problems that might crop up, a panel of experts said Friday.
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The company is fumbling in its attempts to move to a new business model.
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It takes another run at getting FDA approval for its lead drug.
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About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold.
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Two revelations last week of Food and Drug Administration foot-dragging place in doubt whether the agency can effectively serve and protect consumers.
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Our position is: Greater drug safety needs to be coupled with awareness that some risk is inherent in medicine. When it comes to assurances of drug safety, consumers would be advised to heed George Bernard Shaw&#39;s warning to beware of what they wish for.
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In the face of growing public distrust, the US Food and Drug Administration remains unpersuasive in claiming that its review of prescription drugs is sufficient or places the consumer first.
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The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.
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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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Issues of privacy  -  and bureaucracy  -  have hampered health officials trying to avert an outbreak of the disease