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    How FDA Makes Decisions About REMS Requirements for Healthcare Providers

    This article discusses how companies can scrutinize regulatory precedent to best ensure healthcare providers fully understand risks associated with drugs and can safely administer them. The author covers FDA’s requirement that companies develop a Risk Evaluation and Mitigation Strategy (REMS), but highlights the lack of REMs specifics, especially where healthcare provider education and/or training is concerned. She concludes that companies should be proactive in determinin...