300-Page Book, with Foreword by FDA's Janet Woodcock, MD, Provides Practical Guidance on New REMS Requirements
WASHINGTON, May 28 /PRNewswire-USNewswire/ -- Now that the Food and Drug Administration (FDA) has new authority to improve the safe use of pharmaceuticals, drug manufacturers can be required to develop comprehensive risk assessment evaluations and restrict their marketing on existing pharmaceuticals.
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 Administrations Act Amendments of 2007, FDLI has issued the most complete handbook on risk evaluation and management published to date: Pharmaceutical Risk Management: Practical Applications.
This comprehensive, 300-page book, which includes a foreword by Janet
Woodcock, MD, Director of the Center for Drug Evaluation and Research at
FDA, provides practical guidance to enable drug companies to effectively
negotiate the REMS pre- and post-marketing surveillance maze, including:
-- What actions to take to determine if the benefits of a drug outweigh its
-- What to do if FDA decides new safety information requires companies to
make changes in the marketing of existing drugs.
The nuts-and-bolts book also includes instructive 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
-- Crisis management considerations.
The book also contains invaluable appendices, including FDA's guidance for industry on pre-marketing risk assessment.
"Knowing how to design, execute and evaluate a risk management and
communications program can spell the difference betwe
|SOURCE Food and Drug Law Institute|
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