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ESA REMS Allows Oncologists A Year To Enroll In Patient Education Program

Executive Summary

The Risk Evaluation and Mitigation Strategy for erythropoiesis-stimulating agents announced by FDA Feb. 16 focuses on requiring health care providers to educate patients about the risks and benefits of treatment, but stops short of some more restrictive REMS options such as patient registries or controlled distribution

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FDA would like Congress to provide the agency with a larger role in writing Risk Evaluation and Mitigation Strategies, Principal Deputy Commissioner Joshua Sharfstein indicated during a House Energy and Commerce Health Subcommittee hearing on March 10

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