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Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), "a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product." Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices.This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI - Association for the Advancement of Medical Instrumentation.
List of contents
Chapter 1 Introduction
Chapter 2 What is a Combination Product?
Chapter 3 Regulatory Strategies
Chapter 4 cGMPs
Chapter 5 Integrated Development
Chapter 6 Risk Management
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Chapter 8 Lifecycle Management: Design Transfer through Post Market
Chapter 9
- 9A. Best Practices and Considerations for Combination Products Inspection Readiness
- 9B. US Combination Product Inspections
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Chapter 11 Analytical Testing Considerations
Chapter 12 Biological Products Considerations
Chapter 13 Connected Health
Chapter 14 Evolving Global Regulatory Landscape
