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1 Introduction 1
2 Overview and Definitions of Combination Products 7
3 Ensuring Successful Combination Product Development 23
4 Overview of FDA and other Regulatory Agency Expectations 63
5 Resource Requirements 105
6 Manufacturing of Combination Products 119
7 Challenges and Pitfalls to Avoid with Combination Products 137
8 Post Launch Compliance Requirements 181
9 Agency Audits and Challenges 199
10 Conclusions 221
| Price | Condition | Delivery | Seller | Action |
| $140.40 | Digital |
| WonderClub |
Michael Yerton
reviewed Combination Products: Regulatory Challenges and Successful Product Development on October 02, 2014
Combination Products
This book is something to read if you're interested in learning about the field of bio medical engineering and how far it's come in the past half century. If you're looking for one of those books to read while you're drinking coffee with your book club, I don't think this is it. It's something that only a biological science/medicine lover would pick up. Nothing like the watered down NYT bestsellers that brush over topics. It's more of a historical report on engineering in the life sciences. Even the anecdotes are the kind only a scientist would love. I wish that it were a book I could do the former with, so I'm being petty and withholding two stars.
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Add Combination Products: Regulatory Challenges and Successful Product Development, 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, availabl, Combination Products: Regulatory Challenges and Successful Product Development to the inventory that you are selling on WonderClubX
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Add Combination Products: Regulatory Challenges and Successful Product Development, 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, availabl, Combination Products: Regulatory Challenges and Successful Product Development to your collection on WonderClub |
