1st Edition
Combination Products Regulatory Challenges and Successful Product Development
264 Pages
9 B/W Illustrations
by
CRC Press
264 Pages
by
CRC Press
Also available as eBook on:
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,... Read more
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
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
Biography
Smita Gopalaswamy, Venky Gopalaswamy
