Defining “Pollutant”: What You Don't Know Can Hurt You

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.

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Roadmap to risk evaluation and mitigation strategies (REMS) success

Balian

Wherry

Malhotra

et al. 2010

Therapeutic Advances in Drug Safety

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Defining “Pollutant”: What You Don't Know Can Hurt You

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Roadmap to risk evaluation and mitigation strategies (REMS) success

Roadmap to risk evaluation and mitigation strategies (REMS) success

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