FDLI publishes handbook on pharmaceutical risk management.

To help pharmaceutical companies, consultants and other drug industry stakeholders prepare and comply with the new rules on risk evaluation and mitigation strategy (REMS) mandated under the Food and Drug Administration Act Amendments of 2007, the Food and Drug Law Institute (FDLI) has issued a handbook on risk evaluation and management, the organization announced May 28.

"Pharmaceutical Risk Management: Practical Applications" is a 300-page book that "provides practical guidance to enable drug companies to effectively negotiate the REMS pre- and post-marketing surveillance maze," the organization stated in its announcement. Topics include what actions to take to determine if the benefits of a drug outweigh its risks, and what to do if FDA decides new safety information requires companies to make changes in the marketing of existing drugs.

The book also includes chapters on:

* The environmental and historical context for risk management;

* Proven strategies for designing and measuring REMS effectiveness;

* Practical examples and case studies of successful risk management strategies; and

* Crisis management considerations.

The book also contains appendices, including FDA's guidance for industry on pre-marketing risk assessment.

The book was edited by Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide, and former Associate Commissioner at FDA; Jeffrey Fetterman, president and CEO of ParagonRx, a health care consulting firm; and Gary Slatko, M.D., the firm's Chief Medical Officer.

For more information on the book, Pharmaceutical Risk Management: Practical Applications, visit http://www.fdli.org/ or call [phone].