Scientist: FDA Pushed Stance on Drug Use
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A government epidemiologist said Thursday that his bosses asked him to soften his recommendation that antidepressant use by children be discouraged because of increased suicidal behavior among young people who took the drugs.
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The FDA is being accused of approving drugs too quickly, in 1992 Congress passed a new law so that the FDA could speed up drug approvals.
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Doctors have been taking calls from anxious patients ever since a Senate hearing on Vioxx last week at which an FDA scientist expressed concerns about the safety of five other drugs on the market.
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An unsurprising response from the FDA.
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Is the US Food &amp; Drug Administration failing? That was the testimony of one senior FDA official last week concerning Merck&#39;s withdrawal of the Vioxx anti-pain drug.
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One of the nation&#39;s leading cardiovascular medical researchers has issued a call for less aggressive direct-to-consumer advertising and better safety assurances of medications in a special article posted online today by JAMA because of its relevance to
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A previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released today by the Union of Concerned
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In Christopher Rowland's recent article, a Medicare official characterizes FDA drug labeling policy as setting ``minimum guidelines in terms of what people should be achieving" for red blood cell counts ( ``As kidney drug doses rise, so do warnings," Sept. 14 ).
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The Food and Drug Administration takes drug safety and risks seriously and will continue its longstanding practice of assessing the safety of drugs using sound judgment and good science - including peer-reviewed analyses.
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Dr. Steven Galson, acting director of the Food and Drug Administration&#39;s Center for Drug Evaluation, announced Friday that the FDA will review five popular drugs whose safety is being questioned.
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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.
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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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Nearly 20 percent of US Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite
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One of the first researchers to link the popular prescription painkillers Vioxx and Celebrex to heart problems blamed aggressive advertising for escalating
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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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Scientists in the United States and Great Britain are calling for a fresh look at Celebrex and other medications similar to Vioxx, the heavily advertised arthritis
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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.