Combination Products: Regulatory Challenges and Successful Product Development
Gopalaswamy, Smita; Gopalaswamy, Venky
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 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. It addresses the technical, scientific, regulatory, and quality issues that arise when combining drugs, biologics, and medical devices into a single product. It 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.
Specifically, this text explores 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.
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241 pages.
ISBN 978-1-42006-446-9.
Hard Cover.
2008
Item: P1351
Member Price: $139.95
List/Forum-Division Price: $139.95
Related Products:
Combination Products: Regulatory Challenges and Successful Product Development
Gopalaswamy, Smita; Gopalaswamy, Venky
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