Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies.

The book addresses the technical, scientific, regulatory, and quality issues that arise when combining drugs, biologics, and medical devices into a single product.

Combination Products takes a practical, readily applicable approach to discussing the challenges, victories, and pitfalls associated with merging technologies and systems and how to implement these products into the market successfully and in a timely manner.

Features:

• Provides the first in-depth look at combination product development
• Includes practical advice based on years of experience in combination product development, quality control, and regulation
• Offers clear step-by-step guidance, that is concise, comprehensible, and comprehensive
• Outlines FDA and other regulatory guidelines

Combination Products covers the process from start to finish, establishing a workable design and development plan complete with relevant definitions. It reviews FDA and other regulatory expectations and covers resource requirements, manufacturing pitfalls, post-launch compliance requirements, and agency audits and challenges.

Contents

1. Introduction
2. Overview and Definitions of Combination Products
3. Ensuring Successful Development
4. Overview of FDA and other Regulatory Agency Expectations
5. Resource Requirements
6. Manufacturing of Combination Products
7. Challenges and Pitfalls to Avoid with Combination Products
8. Post Launch Compliance Requirements
9. Agency Audits and Challenges

Index

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