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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A team from the Food and Drug Administration met British regulators about their decision to quarantine nearly half the United States' supply of flu vaccine.
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British health officials Friday said their U.S. counterparts knew in mid-September that problems at a drug-manufacturing plant in England could disrupt influenza vaccine supplies to the United States.
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The sudden, major flu vaccine shortage that shocked health authorities last week highlights two vulnerabilities in the nation&#39;s immunization system: a reliance on a few private manufacturers that use old technology, and government&#39;s faith that companies
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As flu season neared in late September, the drugmaker at the center of the vaccine shortage radiated confidence. By Tim Boyle, Getty Images.
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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.
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The Food and Drug Administration has demanded more answers from Chiron Corp. about its efforts to correct operating flaws at the Liverpool plant, where half of the US flu vaccine for this winter was lost to contamination.
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U.S. health regulators sent a  warning letter to Chiron Corp. detailing manufacturing  violations at a British flu vaccine plant and demanding more  information on plans to fix problems that wiped out half of the  U.S. flu shot supply 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 F.D.A. is demanding that Chiron provide more information about its plans to fix widespread sanitary problems at its flu vaccine factory in England.
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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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The FDA decides to debate the company's lead drug.
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GlaxoSmithKline PLC and Novartis AG, two of the world's biggest vaccine makers, may have bet on the wrong technology in the race to develop a better flu shot.
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LONDON - US health officials met with British regulators yesterday to discuss the suspension of flu vaccine production and planned to inspect the Liverpool factory to see whether any impounded vaccine could be salvaged.
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US Food and Drug Administration (news - web sites) Acting Commissioner Lester Crawford on Friday agreed to meet with a top Republican lawmaker about the agency&#39;s handling of safety concerns over Merck &amp; Co Inc.
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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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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.