eBook - PDF
Combination Products
Regulatory Challenges and Successful Product Development
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- 264 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
Combination Products
Regulatory Challenges and Successful Product Development
Book details
Table of contents
Citations
About This Book
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.
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Yes, you can access Combination Products by Smita Gopalaswamy, Venky Gopalaswamy in PDF and/or ePUB format, as well as other popular books in Commerce & Opérations. We have over one million books available in our catalogue for you to explore.
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Table of contents
- Front cover
- Contents
- About the authors
- chapter one. Introduction
- chapter two. Overview of combination products
- chapter three. Ensuring successful combination product development
- chapter four. Overview of FDA and other regulatory agency expectations
- chapter five. Resource requirements
- chapter six. Manufacturing of combination products
- chapter seven. Challenges and pitfalls to avoid with combination products
- chapter eight. Postlaunch compliance requirements
- chapter nine. Agency audits and challenges
- chapter ten. Conclusions
- Index
- Back cover