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FDA Eliminates REMS Requirement for ESAs

Silas Inman @silasinman
Published: Friday, Apr 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 (Epogen/Procrit) and darbepoetin alfa (Aranesp).
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