ABSTRACT

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area.
Providing

chapter 1|6 pages

Introduction

chapter 2|16 pages

Overview of combination products

chapter 5|14 pages

Resource requirements

chapter 6|18 pages

Manufacturing of combination products

chapter 8|18 pages

Postlaunch compliance requirements

chapter 9|22 pages

Agency audits and challenges

chapter 10|14 pages

Conclusions