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Scrip Regulatory Affairs
Amgen/J&J ESAs get REMS in US
03 March 2010
Malini Guha

The US Food and Drug Administration has approved a long-awaited REMS risk-management programme to inform healthcare providers and patients about the well-known risks of the erythropoiesis-stimulating agents (ESAs) marketed by Amgen and Johnson & Johnson1. The REMS (Risk Evaluation and Mitigation Strategy) includes a training programme called APPRISE for doctors who administer the drugs to cancer patients, which will be launched on 24 March...

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