Study Condemns F.D.A.Âs Handling of Drug Safety
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The report is likely to intensify a debate about the safety of the nationÂs drug supply and the adequacy of government oversight.
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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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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. drug safety officer who warned months ago about risks from Merck & Co. Inc.'s painkiller Vioxx won clearance to publish a study arguing the now-recalled drug may have caused up to 139,000 heart attacks and strokes, his attorney said on Monday.
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Many drug company executives say the F.D.A. has quietly become more assertive about keeping new drugs off the market.
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A US Food and Drug Administration official said Friday &quot;we categorically reject&quot; accusations the agency has failed to protect the public against dangerous drugs.
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A Food and Drug Administration  reviewer who has criticized the agency for being lax in  monitoring drug safety said on Thursday five medicines on the  market need close scrutiny for possible side effects.
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Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel.
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A US Food and Drug Administration reviewer who has accused the agency of being lax in monitoring drug safety on Thursday said five medicines on the market need closer scrutiny.
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Users of an anti-arthritis drug linked by a study to an increased risk of heart attacks and strokes are urged not to panic.
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U.S. drug safety regulators are coming under fire for their response to years of suspicions, confirmed last week, that arthritis drug Vioxx increased the risks of heart attacks and strokes.
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Importing cheaper prescription drugs should not come at the expense of safety, said a US government report issued on Tuesday that highlighted the problems of ensuring the medicines are equivalent to those in the United States.
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The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration 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 & Co. Inc.'s withdrawn painkiller  Vioxx.
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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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US drug regulators are warning people not to buy or consume Actra-Rx or Yilishen, a Chinese product for improving men&#39;s sexual performance, because of potential risks.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.