Main description:

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the FDA, "a combination product is one composed of any combination of a drug, a device, and a biological product. Examples include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. This handbook provides the most up to date information on the development of combination products, from the technology involved to successful delivery. The authors present important and up to the minute pre and post market reviews of combination products as well as regulation.

Features :

This handbook provides guidance and regulations to clarify the regulation of combination products.
Reviews medical product classification and assignment issues for agency staff 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

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