FDA Told U.S. Drug System  Is Broken
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The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.
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There was a puzzling line in a report in which the Bush Administration asserted it could not vouch for the safety of foreign, lower-cost prescription drugs.
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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 US Food and Drug Administration, facing a barrage of criticism from both within and outside the agency, announced plans Friday to improve the safety of drugs after they have been approved.
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of the  antibiotic Ketek (Sanofi-Aventis) and some other prescription  drugs on Tuesday.
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A top Food and Drug Administration official said on Thursday she disagrees with an agency scientist&#39;s warning that five drugs on the market have significant safety risks.
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.
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It has been a tough three years for the Food and Drug Administration, which until recently was credited with providing the United States with the safest drug supply in the world.
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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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Dr. Graham said, &quot;The FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.
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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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THE US pharmaceutical industry that exports medicines around the world is facing further scrutiny after a survey revealed nearly one-fifth of its government overseers had experienced pressure to approve drugs about which they had reservations.
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The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.
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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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The U.S. Food and Drug   Administration needs more staff and funding to fix its   monitoring of drug safety after medicines are on the market,   the Institute of Medicine (IOM) said on Friday.
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The US 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 failed the public in its oversight of Merck & Co Inc.'s painkiller Vioxx, which has been withdrawn, and is "incapable of protecting America" from another dangerous drug, an agency researcher told Congress on Thursday.