Roadmap to risk evaluation and mitigation strategies (REMS) success

Abstract

Medical safety-related risk management is a rapidly evolving and increasingly important aspect of drug approval and market longevity. To effectively meet the challenges of this new era, we describe a risk management roadmap that proactively yet practically anticipates risk-management requirements, provides the foundation for enduring yet appropriately flexible risk-management practices, and leverages these techniques to efficiently and effectively utilize risk evaluation and mitigation strategies (REMS)/risk minimization programs as market access enablers. This fully integrated risk-management paradigm creates exciting opportunities for newer tools, techniques, and approaches to more successfully optimize product development, approval, and commercialization, with patients as the ultimate beneficiaries.

Alvimopan, REMS and E.A.S.E! How Are They Related?

“…The previous long term use of alvimopan was associated with life threatening events. This time, US-FDA involved manufacturers in the REMS (Risk Evaluation and Mitigation Strategy) program [4] . The manufacturers of drugs responsible for serious life threatening events earlier were supposed to ensure that benefits of a particular drug or biological product clearly outweighs its risks.…”