Archive for July, 2010

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  FDA Panel Wants Tougher Restrictions on Opioids

  0July 29, 2010
  By Emily P. Walker, Washington Correspondent, MedPage Today — An FDA advisory committee voted 25-10 to reject the agency’s proposed plan...
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  FDA Approves Drug for Chronic Drooling in Children

  0July 28, 2010
  The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic...
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  FDA Approves First Generic Enoxaparin Sodium Injection

  0July 23, 2010
  The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug...
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  REMS Compliance – Review of US REMS Regulation & Compliance

  0July 20, 2010
  FDA regulations regarding risk management have been growing since Thalidomide was found to cause birth defects. The passage of the...
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  FDA and Other Federal Agencies Collaborate to Improve Chemical Screening

  0July 19, 2010
  The U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National...
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  FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers

  0July 16, 2010
  The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been...
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  FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin

  0July 8, 2010
  Serious side effects reported when used to treat or prevent night time leg cramps The U.S. Food and Drug Administration today...
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  FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients

  0July 6, 2010
  Device designed to help those with end-stage, age-related macular degeneration The U.S. Food and Drug Administration today announced it has approved...