Risk management to improve the safety of pharmaceutical products is an emerging discipline that will fundamentally alter the drug development, NDA submission, commercialization and pharmacovigilance processes. Although several risk management programs have been developed, their design, implementation and measurement have been lacking in consistency and adoption by clinicians. To date, little evidence exists to assess program effectiveness. Recognizing these opportunities for improvement, FDA has formally initiated the development of guidance documents, with an intent to finalize them in 2004.

The Foreword is written by Dr. Mark McClellan, former Commissioner of Food and Drugs, and Administrator of Centers for Medicare & Medicaid Services (CMS).

Puzzled by REMS?

In today’s new world of Risk Evaluation and Mitigation Strategy (REMS), drug companies need experienced guidance to help them succeed in pre- and post-marketing drug development and approval. The authors and contributing experts provide you with the day-to-day practical guidance needed to understand, plan and implement successful risk management programs. Each chapter is a stand-alone dissertation by a contributing expert on a specific segment of risk management. Included are chapters on the environmental and historical context for risk management; examples and case studies; strategic considerations in program design; approaches to crisis management and legal implications of risk management. This publication offers insight into the FDA’s evolving thinking on the REMS process and application.

With a Foreword by Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research.