written on 27.06.2014

Risk Evaluation and Mitigation Strategy (REMS) in Oncology from 2008 to Date


Risk Management is defined in FDA Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment as an iterative process of: assessing a product’s benefit-risk balance, developing and implementing tools to minimize its risks while preserving its benefits, evaluating tool effectiveness and reassessing the benefit-risk balance, and making adjustments, as appropriate, to the risk minimization tools […]