Short description:

Provides the most up to date information on the development of combination products, from the technology involved to successful delivery. This handbook discusses important and up to the minute pre and post market reviews of combination products as well as regulation.

Long 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:

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