jueves, 24 de septiembre de 2015

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. Clozapine shared system REMS approved (on September 15, 2015).
  2. Pomalyst REMS modified (on September 14, 2015) and Thalomid REMS and Revlimid REMS modified (on September 13, 2015) to include mobile applications into the REMS materials to provide an additional platform to accomplish internet-capable REMS activities.
  3. Isotretinoin iPLEDGE shared system REMS modified (on September 3, 2015) to minimize the burden on the healthcare delivery system of complying with the REMS by:
    • Changing the Request for Exemption for Patients with Serious Medical Reasons.
    • Standardizing the terminology for female patients of childbearing potential in the REMS document, and appended REMS materials to “Females of Reproductive Potential (FRP)” and “Females of Non-Reproductive Potential (FNRP),” where applicable.
  4. Myalept REMS modified (on August 27, 2015) to transfer of ownership from Amylin Pharmaceuticals to Aegerion Pharmaceuticals, Inc.

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