Archive for May, 2010

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  FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli

  0May 26, 2010
  The U.S. Food and Drug Administration today advised consumers and health care professionals about potential rare occurrences of severe liver...
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  FDA Announces Collaboration with Drugs.com

  0May 26, 2010
  The U.S. Food and Drug Administration announced today that it will collaborate with the Web site Drugs.com to expand access...
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  FDA: Possible Fracture Risk with High Dose, Long-term Use of Proton Pump Inhibitors

  0May 25, 2010
  Labeling changes will include new safety information The U.S. Food and Drug Administration today warned consumers and health care professionals about...
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  FDA Approves New Treatment for Late-Onset Pompe Disease

  0May 25, 2010
  The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile)...
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  FDA and NIH Launch Electronic Safety Reporting Portal

  0May 24, 2010
  The Food and Drug Administration and the National Institutes of Health today launched a new Web site that, when fully...
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  Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give up $175 Million in Profits

  0May 24, 2010
  Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and...
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  FDA Clears First 2009 H1N1 Influenza Virus Test Previously Available Under Emergency Use Authorization

  0May 24, 2010
  Clearance will allow continued use of Simplexa Influenza A H1N1 (2009) test The U.S. Food and Drug Administration today announced it...
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  ORTHO-McNEIL PHARMACEUTICAL, LLC PLEADS GUILTY TO ILLEGAL PROMOTION OF TOPOMAX

  0May 21, 2010
  BOSTON, Mass. – ORTHO-McNEIL PHARMACEUTICAL, LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in...
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  FDA Transparency Task Force Unveils Draft Proposals on Agency Disclosure Policies

  0May 19, 2010
  The U.S. Food and Drug Administration’s Transparency Task Force today released 21 draft proposals for public comment on public disclosure...
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  7th Forum on Late Phase Research, Drug Safety and Risk Management

  0May 11, 2010
  February 24 – 25, 2011 in London , United Kingdom ~ CBI’s 6th Forum on Late Phase Research, Drug Safety and...