U.S. Officials Mull Drug Safety Independence
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Health and Human Services Secretary Tommy Thompson is expected to announce changes to give the FDA's Office of Drug Safety more autonomy.
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About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency&#39;s monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
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US drugs regulators made two trips to Capitol Hill last week to defend themselves before Congress. They are likely to return soon, after their efforts to reassure lawmakers and the public
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WASHINGTON -- Efforts to allow Americans access to cheaper prescription drugs from abroad should blossom once Democrats assume control in Congress, but the issue won't be a top priority, lawmakers and healthcare experts said.
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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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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 U.S. Food and Drug  Administration said on Tuesday it was creating an independent  drug safety board after the agency's monitoring of drugs  already in the marketplace was criticized amid the withdrawal  of arthritis drug Vioxx.
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When a congressional committee holds a hearing next Wednesday, the subject will be the safety of the diabetes drug Avandia and whether federal drug regulators have paid close enough attention to its potential risks.
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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 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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Importing cheaper prescription medicines would require costly safety measures and save US consumers little money, a government task force said on Tuesday in a report
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The head of the U.S. drug safety  agency on Tuesday said the United States was keeping "all  regulatory options open" as it studied data showing increased  heart risks from some painkillers.
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Proposed legislation could spell changes across the pharmaceutical world.
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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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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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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.