viernes, 24 de junio de 2016

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS) website updated

REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
1. Sabril REMS modified (June 21, 2016) to:
    • modify the goals
    • remove the Medication Guide and communication plan as elements of the REMS
    • remove ETASU that require:
      • each patient using the drug be enrolled in a registry
    • modify ETASU that require:
      • healthcare providers who prescribe the drug have particular training or experience, or are specially certified
      • pharmacies, practitioners, or healthcare settings that dispense the drug are specially certified
      • the drug be dispensed to patients with evidence or other documentation of safe-use conditions
    • modify the implementation system
    • modify the timetable of submission of assessments
    2. Probuphine REMS revised (June 26, 2016) to correct a typographical error(s)
    3. Entereg REMS revised (June 14, 2016) to change the application holder’s name or address.

    Learn more about how to use the REMS@FDA website through this tutorial. 

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