FDA denies knowing of Chiron suspension
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The acting Food and Drug Administration (FDA) commissioner on Monday disputed a published report that said agency officials knew before Oct. 5 that British health authorities might suspend
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Chiron Corp. is working with British  regulators who suspended its license to sell a flu vaccine and  is hoping authorities will lift the suspension in time for the  2005/2006 flu season, the company said on Friday.
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None of the 5 million or 6 million doses of influenza vaccine made by Chiron Corp. and currently warehoused in the United States has been given to the public, a Food and Drug Administration official said yesterday.
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The Food and Drug Administration uncovered contamination and unsanitary conditions at a British flu vaccine manufacturing plant in 2003 but failed to re-inspect it until similar problems caused the loss of half the U.S. vaccine supply in October, the top FDA official said Wednesday.
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The Food and Drug Administration yesterday again denied that the agency had any early indications that there were serious problems at a British
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The U.S. 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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In a hearing on the national flu vaccine shortage, the House Energy and Commerce Subcommittee on Health on Thursday requested that FDA, HHS and flu vaccine manufacturer Chiron by Dec. 1 produce documents detailing
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WASHINGTON - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday...
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Chiron Corp. is being investigated by the US Justice Department over the suspension of its flu vaccine factory in the UK because of contamination, the company said in a regulatory filing.
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U.S securities regulators have launched  an informal civil investigation into whether Chiron Corp.  failed to adequately disclose the extent of problems at its  flu-vaccine production plant in England, according to the  online edition of the Wall Street Journal.
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Edwards Lifesciences Corp. (EW.N: Quote, Profile, Research) on Friday said it does not expect the US Food and Drug Administration to provide an answer on whether it can conduct a clinical
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The Food and Drug Administration ignored danger signals from its own scientists about Merck and Co. Inc.'s Vioxx painkiller, Sen. Charles Grassley told a hearing Thursday into the drug's withdrawal in September.
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The FDA says that although its decision is to not ban the drug, that possibilty is not ruled out. NEW YORK (CNN/Money) - The US Food and Drug Administration decided Friday not to recall Celebrex but it has not ruled out the possibility.
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Chiron Corp. is being investigated by  a federal grand jury after failing to deliver flu vaccine this  year because regulators did not consider it safe.
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Britain suspended on Tuesday the manufacturing license of Chiron Corp., a major supplier of flu vaccine to the United Kingdom and the United States, for three months.
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Food and Drug Administration approval of a drug label does not clear the manufacturer of claims that its warnings were inadequate, a judge ruled.
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WASHINGTON - The US Attorney in New York has subpoenaed information from Chiron, the major flu vaccine supplier for the US, on the unexpected shutdown of a plant in Great Britain.