FDA Faulted In Safety Lapses
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The Food and Drug Administration came under withering criticism by a House panel yesterday for its handling of recent food-safety violations, and the Bush administration later disclosed plans to establish a working group to review the safety of food and other imports.
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US health regulators say they found quality-control problems at a flu vaccine factory in Liverpool, England, in June 2003 but did not begin a full inspection of the plant again
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Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior
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About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold.
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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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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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A top Republican lawmaker raised  concerns about the U.S. Food and Drug Administration's ability  to monitor drug safety following Merck & Co. Inc.'s recall of  its arthritis drug last week, according to a letter made public  on Tuesday.
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Americans are exposed to dangerous medicines because drug makers do not adequately disclose side effects and regulators are failing to react fast enough to safety risks, according to a prominent medical journal.
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The recent Vioxx withdrawal and  testimony from an FDA insider accusing the agency of failing to  protect public health are fueling such heightened concern over  drug safety that valuable medicines could be kept from  patients, doctors said on Friday.
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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 Food and Drug Administration of the US found itself in the midst of a rather unpleasant controversy. Recently the chief of Cleveland Clinic Foundationâs department of cardiovascular medicine blamed this
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U.S. health officials evaluated the wrong factory when assessing the safety of a Chinese-made drug ingredient that may be a source of problems with a blood thinner, the Food and Drug Administration said Monday.
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There are two problems at the FDA. The first is that the Fraud and Drug Administration clearly puts the protection of Big Pharma profits as its primary mission, rather than protecting the public from dangerous drugs.
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of a  Sanofi-Aventis antibiotic and some other prescription drugs on  Tuesday.
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The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.
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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of a Sanofi-Aventis antibiotic and some other prescription drugs on Tuesday.
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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.