Report Lists Faults of F.D.A. Drug-Safety Process
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The agency is plagued with poor management and persistent internal squabbling, according to the report.
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The U.S. Food and Drug Administration 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to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.
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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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NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.
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Health care advocates, providers and FDA officials over the weekend &#39;sparred&#39; over alleged problems with the FDA prescription drug safety review process and the safety of five medications currently on the market, after an FDA safety reviewer on Thursday
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Two years after the withdrawal of the painkiller Vioxx, a dysfunctional Food and Drug Administration still can't adequately track the safety of new drugs and respond quickly to problems, a panel of experts said Friday.
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A new report reveals an alarming rise in fatal or debilitating prescription drug-related side effects and raises serious questions about basic medical safety practices.
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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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A report presented to the House Government Reform Committee shows that the Food and Drug Administration discovered contamination at the Chiron Corp.
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After two highly publicized incidents questioning the safety of some of the biggest selling prescription medicines, the Food and Drug Administration said yesterday it is moving to strengthen its safety monitoring efforts.
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Although the volume of prescription drugs and drug ingredients coming into the country from foreign manufacturers in developing nations such as India and China has exploded in recent years, the Food and Drug Administration's budget for foreign inspections has not kept pace and will be lower in 20...
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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of the antibiotic Ketek (Sanofi-Aventis) and some other prescription drugs on Tuesday.
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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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Two-thirds of scientists working for the US medicines regulator have expressed a lack of confidence in the federal safety monitoring of prescription drugs, according to documents disclosed by two lobby groups.
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Nov. 19, 2004 -- New allegations from an FDA scientist that the agency is failing at its job of ensuring the safety of the drugs it approves has many Americans thinking twice before taking their daily dose.
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Description: Faced with a series of major lapses in drug safety, the Food and Drug Administration announces new measures to rectify the situation.