F.D.A. Failing in Drug Safety, Official Asserts
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Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel.
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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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Description: A Bush administration task force has raised serious doubts about whether drugs imported from abroad can be made safe.
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A series of drug-safety scandals has led many on Capitol Hill to question whether the F.D.A. has failed to strike the right balance between speed and safety.
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A US Food and Drug Administration official said Friday &quot;we categorically reject&quot; accusations the agency has failed to protect the public against dangerous drugs.
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A drug safety reviewer said the FDA is "incapable of protecting" the public and urged the government to review five new drugs for safety issues.
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Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior regulator who has launched a campaign to improve the ratio.
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A scientist working at the US Food and Drug Administration accuses the agency of "profound failure" in its oversight of the recently withdrawn arthritis drug Vioxx.
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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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Dozens of former and current Food and Drug Administration officials, outside scientists and advocates for patients say that the agency&#39;s efforts to monitor the ill effects of drugs that
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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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The federal Food and Drug Administration&#39;s ability to protect the American public is in question in the wake of the problems with this year&#39;s flu vaccine shortage and claims that it is allowing unsafe drugs to remain on the market.
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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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The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
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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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Senator Judd Gregg (USA) does not like the idea of a new independent bureau responsible for drug safety. He says all it would achieve would be more layers of FDA bureaucracy.
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A US Food and Drug Administration official who attempted to publish his negative findings about the now-withdrawn painkiller Vioxx said that agency officials ridiculed the results and ultimately delayed publication, The New York Times reported Thursday.