Vaccine maker, FDA talk
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PHILADELPHIA -- GlaxoSmithKline is in talks with the Food and Drug Administration about selling its Fluarix influenza vaccine in the United States this season because of the expected flu vaccine shortage this year.
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TORONTO (CP) - Officials of the US Food and Drug Administration will inspect the Ste-Foy, Que., flu vaccine production plant of ID Biomedical next week in a bid to approve the company&#39;s surplus vaccine for importation to the United States.
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The US Food and Drug Administration yesterday sought to distance itself from remarks by one of its top safety officials that raised concerns about key drugs made by Astrazeneca and Glaxo Smithkline.
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Executives at the Chiron Corporation hedged yesterday about whether the company would be able to return to selling flu vaccine in the United States next year.
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TORONTO -- Canada&#39;s chief public health officer defended yesterday the right of the country&#39;s flu vaccine manufacturer to sell surplus supply to the United States.
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British and American drug regulators met yesterday to see what could be done about the stopped batches of flu vaccines at Chiron&#39;s Liverpool production plant, UK.
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WASHINGTON -- Flu vaccine manufacturer Chiron has three weeks to respond to a Food and Drug Administration warning letter that alleges violations of FDA regulations at the company&#39;s plant in Liverpool, England, where contamination problems led to the US
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GlaxoSmithKline Plc is exploring ways to  sell its Fluarix flu vaccine in the United States, where  supplies have run short this season after Chiron Corp lost a  year's production to contamination.
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U.S. Food and Drug Administration Acting Commissioner Lester Crawford on Friday agreed to meet with a top Republican lawmaker about the agency's handling of safety concerns over Merck & Co Inc.'s now-withdrawn painkiller Vioxx.
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Some lawmakers on Capitol Hill are criticizing the FDA for not adequately overseeing a British plant making flu vaccine for sale in the United States.
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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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US health officials Monday denied reports that they knew before last week that there were major production problems with a key American manufacturer&#39;s flu vaccine, which
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U.S. health officials are talking with several flu vaccine producers worldwide in hopes of securing doses to protect millions left vulnerable when manufacturing problems cost the country half its supply.
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The World Health Organization is urging drugmakers including GlaxoSmithKline Plc, Sanofi-Aventis SA and Chiron Corp. to join in developing a vaccine to stop Asia&#39;s deadly bird flu virus from triggering a pandemic.
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Some members of Congress are taking the US Food and Drug Administration to task for the agency&#39;s assertions that contamination problems at a major flu vaccine supplier took the FDA by surprise, The New York Times reported Thursday.
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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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GlaxoSmithKline said on Monday that U.S. regulators were seeking further information prior to the possible approval of cervical cancer vaccine Cervarix.