FDA Official Defends Drug Safety Record
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A top official of the US Food and Drug Administration said Friday that he and his colleagues &quot;categorically reject&quot; earlier Congressional testimony that the agency has failed to protect the public against dangerous drugs.
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WASHINGTON -- The Food and Drug Administration is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx during an FDA meeting next week on heart risks posed by the drugs, a US senator charged.
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British drug firms have defended the safety of two products which were deemed unsafe by an American expert. Dr David Graham listed five medicines which he said posed serious health risks during a US Senate hearing.
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The Bush administration and some of its critics squared off over whether the Food and Drug Administration is doing an adequate job overseeing drug safety, and whether the agency needs major reforms. White House Chief of Staff Andrew H. Card Jr. said it is doing a "spectacular" job.
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The US Food and Drug Administration asked David Graham, who last month told a Senate committee that the agency fails to protect the public from dangerous medicines, to leave his position
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The potential heart risks of GlaxoSmithKline Plc's diabetes drug Avandia are still not clear, the head of the U.S. Food and Drug Administration told lawmakers who questioned the agency's oversight of the widely used pill on Wednesday.
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Two-thirds of Food and Drug Administration scientists surveyed two years ago lacked confidence that the FDA adequately monitors the safety of prescription drugs, a report released Thursday shows.
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A Food and Drug Administration official who sought to estimate the harm done to patients by side effects of the painkiller Vioxx said yesterday that his supervisors tried to suppress his conclusions, according to Sen.
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All studies to date provide inconsistent data about the potential contribution of GlaxoSmithKline Plc's diabetes drug Avandia to heart attack risk, the head of the Food and Drug Administration said in testimony prepared for a congressional hearing on Wednesday.
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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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An internal survey of Food and Drug Administration scientists conducted by the Health and Human Services Office of the Inspector General revealed safety concerns about the FDAâs approval process and monitoring of marketed drugs, according to a press
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A20-YEAR veteran of federal drug safety wars sent shock waves through the Food and Drug Administration and the pharmaceutical industry when he told a Senate hearing that regulators are &quot;incapable of protecting America against another Vioxx.
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A US government drug-safety scientist told lawmakers that the US Food and Drug Administration is &quot;virtually defenseless&quot; against a possible drug catastrophe like Merck&#39;s arthritis drug Vioxx.
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A document released by the FDA outlines its concerns with GPC's lead drug.
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The U.S. Food and Drug Administration  said on Friday that Senate testimony by a veteran FDA  researcher regarding safety risks for five drugs does not  reflect the views of the agency.
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The U.S. Food and Drug Administration denied charges it tried to suppress a safety official's findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
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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.