FDA Says Stands by Safety of Approved Drugs
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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 regulatory approval was also a boost for the embattled drugs sector. It was feared that, following a series of safety crises, the US Food and Drug Administration would get tougher on new drugs.
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After two highly publicized incidents questioning the safety of some of the biggest selling prescription medicines, the Food and Drug Administration said yesterday it is moving to strengthen its safety monitoring efforts.
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The Food and Drug Administration has signed off on the safety of a portion of five (m) million doses that are available from plants in Canada and Germany.
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A top Food and Drug Administration official said on Thursday she disagrees with an agency scientist's warning that five drugs on the market have significant safety risks.
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WASHINGTON - The Food and Drug Administration would gain authority to ensure the safety of prescription drugs, including the power to mandate label changes that warn of newly emerging risks, under a bill passed yesterday by the House.
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The American public is &quot;virtually defenseless&quot; if another medication such as Vioxx proves to be unsafe after it is approved for sale, a government drug safety reviewer told a congressional committee Thursday.
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British drug firms have defended the safety of two products which were deemed unsafe by an American expert. Dr David Graham listed five medicines which he said posed serious health risks during a US Senate hearing.
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The US Food and Drug Administration (news - web sites) on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck &amp; Co.
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The U.S. Food and Drug Administration said on Tuesday it was creating an independent drug safety board after the agency's monitoring of drugs already in the marketplace was criticized amid the withdrawal of arthritis drug Vioxx.
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The US Food and Drug Administration (FDA) has issued final regulations on the establishment and maintenance of records to protect the US human food and animal feed supply in the event of credible threats of serious adverse health consequences or death to
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The US Food and Drug Administration today announced a five-step program to bolster drug safety evaluations. The news comes after controversy over the recall of the arthritis drug Vioxx and risks to children on antidepressants.
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The U.S. House of Representatives  approved a bill on Wednesday aimed at strengthening Food and  Drug Administration drug safety oversight and raising  pharmaceutical industry fees that help speed product reviews.
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WASHINGTON -- A Food and Drug Administration official is defending the agency&#39;s action with regards to Vioxx. The drug was taken off the market Sept.
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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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Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite
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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.