Combination Products: Regulatory Challenges and Successful Product Development by Venky Gopalaswamy, Smita Gopalaswamy

From the Publisher

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.

Product Details

• ISBN: 1420064460
  
• ISBN-13: 9781420064469
• Format: Hardcover, 241pp
• Publisher: CRC Press
• Pub. Date: April 2008
• Sales Rank: 154,754

• Table of Contents

Table of Contents