Oncologists: Classwide ESA REMS Equals Administrative Burden

The American Society of Clinical Oncology is drafting a letter to the FDA citing concerns that the society was excluded from the agency’s development of a classwide risk evaluation and mitigation strategy (REMS). The letter is related to a REMS for Amgen’s three erythropoiesis-stimulating agents (ESAs) that took effect March 24.
Drug Industry Daily