Agency doctors say post-market studies can&#39;t be required
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WASHINGTON (CBS.MW) -- The US Food and Drug Administration could not force Merck to perform safety studies of arthritis drug Vioxx after it hit the market in 1999, but the agency successfully &quot;negotiated&quot; the long-term studies that uncovered Vioxx&#39;s heart
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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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The Food and Drug Administration said yesterday that it does not plan to follow the lead of Canadian regulators who took a drug for attention-deficit hyperactivity disorder off the market because of reports that it has been linked to 20 sudden deaths and a dozen strokes, including some among children.
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Researchers say results aren't necessarily transferable to human beings.
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Patients who fail to follow medical advice will not be penalised under a reformed NHS, minister says.
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WASHINGTON - 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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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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Two US regulators defended the Food and Drug Administration's handling of the withdrawn painkiller Vioxx, disputing the contention of heart researcher Dr. Eric Topol that the agency could have forced Merck &amp; Co. to do more safety testing.
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A report to be released on Friday finds the U.S. Food and Drug Administration does very little to ensure the safety of patients who help test drugs in clinical trials, The New York Times reports.
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Medical researchers said the U.S. needs a system independent of the F.D.A. to detect harmful effects of drugs already on the market.
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Oncologists do not usually need bodyguards when they present scientific data at a medical symposium.
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Private firms should not offer body scans to people without any symptoms, a government advisory panel says.
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U.S. health officials said on   Tuesday they were re-evaluating rules that allow the testing of   unapproved emergency treatments without patient consent, a   practice that came under fire in recent studies of potential   blood substitutes.
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The Food and Drug Administrationâs proposed rules would allow drug and device makers to provide doctors with medical journal articles about product uses that have not been approved by the F.D.A.
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Drug and medical device makers will not be forced to disclose the results of clinical trials on some products that never reached the marketplace.
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The US Food and Drug Administration denied charges it tried to suppress a safety official&#39;s findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
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Nearly 20 percent of U.S. Food and  Drug Administration scientists surveyed in late 2002 said they  were pressured to approve or recommend approval of a medicine  despite their reservations about the drug's risks or  effectiveness, according to documents made public on Thursday.