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Risk evaluation and mitigation strategies – the impact on practitioners

  • In: C4 - Gaps in Drug Development and strategies to avoid the risk and increase drug safety on Tuesday, 31 August 2010, 9:00-12:00
  • At: Lisbon (Portugal) (2010)
  • Type: Presentation
  • By: CHEN, David (American Society of Health-System Pharmacists, Bethesda, United States of America)
  • Abstract:

    The FDA in its pursuit to improve drug safety in the United States has enhanced post marketing surveillance and has implemented Risk Evaluation and Mitigation Strategies (REMS) for medications with actual or potential safety concerns. It is through the Food and Drug Administration Amendments Act (FDAAA) of 2007 which grants the FDA new authorities

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Last update 28 September 2023

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