1st Edition
Combination Products Regulatory Challenges and Successful Product Development
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
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.
Biography
Smita Gopalaswamy, Venky Gopalaswamy
