jueves, 1 de diciembre de 2016

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

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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. Iclusig REMS modified (November 28, 2016) to update data regarding the incidence of arterial occlusive and venous thromboembolic events in the Letter for Healthcare Providers, Letter for Professional Societies, Factsheet, and website.
2. Xiaflex REMS modified (November 28, 2016) to:
  • Remove the communication plan
  • Release the REMS requirements for the Dupuytren's contracture indication
  • Change the Prescriber Material, “Training Guide for the Administration of Xiaflex for Peyronie’s Disease”
  • Change the Patient Counseling Tool, “What You Need to Know About XIAFLEX Treatment for Peyronie’s Disease: A Patient Guide”
  • Align the Training Video with the Prescriber Material
  • Align the Xiaflex REMS Program website to align with the Prescriber Material and remove information related to the communication plan
3. Xultophy REMS approved (November 21, 2016).
4. Myalept REMS revised (November 7, 2016) to correct a typographical error(s).
5. Extraneal REMS modified (October 24, 2016) to add two new glucose monitor manufacturing companies to the REMS materials, remove the reference to patient surveys from the REMS document, and update the version number in the REMS materials.
6. Adasuve REMS revised (October 19, 2016) to change the application holder’s name or address.