FDA Eliminates REMS Requirement for ESAs

April 14, 2017 – The FDA has eliminated the need for risk evaluation and mitigation strategy (REMS) certification prior to the administration of erythropoiesis-stimulating agents (ESAs) for anemia due to myelosuppressive chemotherapy. The decision applied specifically to the agents epoetin alfa and darbepoetin alfa. “The FDA has released the REMS requirements for the ESA products, Epogen/Procrit and Aranesp, and the risks can be communicated by the current product … (leggi tutto)