Description
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.
Table of Contents
Foreword
Part 1: Foundation
Chapter 1 Introduction
John Barlow Weiner
Chapter 2 What is a Combination Product?
Susan Neadle
Chapter 3 Regulatory Strategies
Suzette Roan
Chapter 4 cGMPs
Susan Neadle and Mike Wallenstein
Chapter 5 Integrated Development
Susan Neadle
Chapter 6 Risk Management
Susan Neadle, Richard Wedge, and Edwin Bills
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Shannon Hoste, Stephanie Canfield, Susan Neadle, Bjorg Hunter, Theresa Scheuble
Chapter 8 Lifecycle Management: Design Transfer through Post Market
Susan Neadle and Khaudeja Bano
Chapter 9
9A. Best Practices and Considerations for Combination Products Inspection Readiness
Susan Neadle
9B. US Combination Product Inspections
Kim Trautman
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Fran DeGrazio and Meera Raghuram
Chapter 11 Analytical Testing Considerations
Daniel Bantz and Jennifer Riter
Chapter 12 Biological Products Considerations
Manfred Maeder
Chapter 13 Connected Health
Ryan McGowan
Chapter 14 Evolving Global Regulatory Landscape
Stephanie Goebel, Viky Verna, Chery Marty and Susan Neadle
Appendices
- Comparative Overview of Global Combination Product Regulatory Landscape
Dhiraj Behl and Susan Neadle
- Glossary
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