Does Leadership Count at the FDA?
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Taking a look at how drug approval rates have fared under different FDA commissioners.
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WASHINGTON - Congress is looking into whether the Food and Drug Administration shirked its duty by ignoring safety concerns about Vioxx raised by its own reviewers and outside scientists.
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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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We can&#39;t isolate ourselves from every danger. That was the message from the Food and Drug Administration. We can&#39;t isolate ourselves from the danger of the FDA.
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Dr. David Graham, the Food and Drug Administration scientist who publicly criticized the agency&#39;s approach to drug safety during a congressional hearing last week, said
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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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Amid intense criticism that it is slow to raise the alarm about unsafe medicines, the Food and Drug Administration announced Friday that it would hire the nation&#39;s top
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Medarex's lead drug gets an important yet expected designation from the FDA.
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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October 1, 2004 5:11 PM GMT (Datamonitor) - The Food and Drug Administration (FDA) is set to examine the potential link between antidepressants and increased suicidal tendencies in adults.
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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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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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Top women executives do slightly better at U.S.-based healthcare and pharmaceutical companies than in other industries, but 35 percent of big drug companies do not have a single female director, according to a new survey.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration will ask the Institute of Medicine to study the  agency's safety monitoring of medicines already on the market,  Acting FDA Commissioner Lester Crawford said on Friday.
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Saying there is evidence the Food and Drug Administration is suppressing scientific reports and maintaining too cozy a relationship with drug companies it regulates, US Sen. Charles Grassley of Iowa today will hold a hearing on the drug Vioxx.
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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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The Bush administration and some of its critics squared off yesterday over whether the Food and Drug Administration (FDA) is doing an adequate job overseeing drug safety, and whether the agency needs major reforms.