Lawmakers blast FDA drug safety oversight
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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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Democrats attacked U.S. drug regulators for missing "repeated opportunities to correct" problems at the plant where contaminated flu shots led to the current shortage.
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Two-thirds of scientists working for the US medicines regulator have expressed a lack of confidence in the federal safety monitoring of prescription drugs, according to documents disclosed by two lobby groups.
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An internal survey finds about two-thirds of FDA scientists lack confidence in the agency&#39;s monitoring of the safety of prescription drugs now on the market.
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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Food and Drug Administration failed the public in its oversight of Merck & Co Inc.'s painkiller Vioxx, which has been withdrawn, and is "incapable of protecting America" from another dangerous drug, an agency researcher told Congress on Thursday.
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The editors of the Journal of the American Medical Association (JAMA) are calling for an end to the US Food and Drug Administration&#39;s (FDA) role in post-market monitoring of the safety of drugs it approves.
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Congressional Democrats attacked  U.S. drug regulators on Wednesday for failing to recognize that  flu vaccine was contaminated with bacteria at Chiron Corp.'s  British plant after problems first arose in 2003.
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U.S. Food and Drug Administration  officials pressured an agency safety official to keep quiet or  water down his findings that the now-withdrawn arthritis drug  Vioxx was dangerous to the heart, a leading Senate Republican  charged on Thursday.
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A top Republican lawmaker on  Thursday charged the U.S. Food and Drug Administration with  hindering a congressional investigation into whether the agency  suppressed a possible link between antidepressant use and  suicidal behavior in youth.
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Calls for changing the way the government monitors drug safety erupted Friday, as consumer advocates and worried patients zeroed in on testimony that five federally approved medicines posed significant health risks.
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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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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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At a hearing Thursday on Capitol Hill, senators excoriated top federal drug regulators for failing to realize three years ago that Vioxx, a pain pill that Merck withdrew in September, was dangerous.
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A top Republican lawmaker raised concerns about the US Food and Drug Administration&#39;s ability to monitor drug safety following Merck &amp; Co.
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Concerns over the approval of drugs that turned out to be dangerous have led Republicans and Democrats in the House and the Senate to call for investigations.
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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.