FDA Takes Issue With Boston Scientific
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Boston Scientific receives a warning letter from the FDA on a discontinued stent trial.
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The U.S. Congress began  investigating on Wednesday whether the U.S. Food and Drug  Administration overlooked problems at a British plant that led  to the withdrawal of half the country's flu vaccine supply.
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Congress started an investigation on Tuesday into whether the U.S. Food and Drug Administration overlooked problems at a British plant that led to the withdrawal of half the country's flu vaccine supply.
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As the nation prepared for a severe shortage of flu shots, the Food and Drug Administration said Monday that problems at the British plant that manufactured vaccine withheld by British authorities likely will be used as a "test case" to lobby for better information-sharing with European regulators.    Last Tuesday, British authorities blocked Chiron Corp...
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The US Food and Drug Administration, under fire for its alleged failure to monitor the safety of drugs after they have been approved, is now facing criticism over its lack of leadership during the Bush administration.
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A drug manufacturer has been found to infringe patents licensed by the maker of a rival drug.
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The Food and Drug Administration failed to heed repeated warnings of contamination at Chiron&#39;s now-shuttered British flu-vaccine plant and the urging of US inspectors
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The Food and Drug Administration is unlikely to sanction Boston Scientific Corp. after reviewing its handling of safety recalls of its new cardiac stent system, an agency official said yesterday.
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Boston Scientific Corp. BSX.N on   Thursday said an internal analysis confirmed an increased risk   of blood clots with its drug-coated device used to keep   previously clogged arteries open.
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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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If its latest drug isn't approved, the pharmaceutical could face trouble.
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Shares in Boston Scientific Corp. slumped yesterday after the company said its top-selling product can cause blood clots in patients' coronary arteries.
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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.
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A document released by the FDA outlines its concerns with GPC's lead drug.
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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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Critics charge conflict of interest in a system where pharmaceutical giants fund the regulatory process. By Alexandra Marks | Staff writer of The Christian Science Monitor.
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The federal Food and Drug Administration&#39;s ability to protect the American public is in question in the wake of the problems with this year&#39;s flu vaccine shortage and claims that it is allowing unsafe drugs to remain on the market.