The Combination Products Handbook: A Comprehensive Guide to Developing and Regulating Combination Products and Other Combined Use Systems
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Provides a comprehensive overview of the regulatory framework for combination products, including FDA, EMA, and PMDA regulations.
Offers practical guidance on developing combination products, including design, testing, and clinical trials.
Covers the latest advances in combination product technology, including drug-device combinations, biologic-device combinations, and medical device-diagnostic combinations.
Includes case studies and examples of successful combination product development and regulation.
Written by a team of experts from industry, academia, and regulatory agencies.
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