Archive for August, 2010

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  Discussion Forum

  2August 18, 2010
  Discuss any general REMS related topics here.
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  FDA Proposes Withdrawal of Low Blood Pressure Drug

  0August 16, 2010
  Companies failed to provide evidence of clinical benefit of midodrine hydrochloride  The U.S. Food and Drug Administration today proposed to withdraw...
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  FDA approves ella™ tablets for prescription emergency contraception

  0August 13, 2010
  The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy...
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  FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal

  0August 12, 2010
  The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder,...
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  FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making

  0August 4, 2010
  Recommendations focus on innovation, regulatory predictability, and patient safety  The U.S. Food and Drug Administration today issued two comprehensive evaluations containing...