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Combination Products: Regulatory...

Combination Products: Regulatory Challenges and Successful Product Development

Name: Combination Products: Regulatory Challenges and Successful Product Development
ISBN: 9781420064469

Smita Gopalaswamy, Venky Gopalaswamy

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The field of combination product development is so new that very few publications, including FDA documents, are available. This text provides an overview of the process from start to finish, complete with relevant definitions, and then shows how to establish a design and development plan. It provides an overview of FDA and other regulatory expectations and covers resource requirements, manufacturing, pitfalls, post-launch compliance requirements, and agency audits and challenges. The book presents practical guidelines on how to develop combination products successfully and how to implement these products into the market successfully and in a timely manner.

వర్గాలు:

Business & Economics - Management & Leadership

సంవత్సరం:

2008

ముద్రణం:

ప్రచురణకర్త:

CRC Press

భాష:

english

పేజీల సంఖ్య:

260

ISBN 10: