Combination Products: Regulatory Challenges and Successful Product Development

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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Combination Products: Regulatory Challenges and Successful Product Development

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

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Combination Products: Regulatory Challenges and Successful Product Development

Combination Products: Regulatory Challenges and Successful Product Development

Combination Products: Regulatory Challenges and Successful Product Development

Combination Products: Regulatory Challenges and Successful Product Development

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Overview

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


Product Details

ISBN-13: 9781040068960
Publisher: CRC Press
Publication date: 04/22/2008
Sold by: Barnes & Noble
Format: eBook
Pages: 264
File size: 2 MB

About the Author

Smita Gopalaswamy, Venky Gopalaswamy

Table of Contents

Introduction. Overview and Definitions of Combination Products. Ensuring Successful Development. Overview of FDA and other Regulatory Agency Expectations. Resource Requirements. Manufacturing of Combination Products. Challenges and Pitfalls to Avoid with Combination Products. Post Launch Compliance Requirements. Agency Audits and Challenges. Conclusions.
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