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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics 2nd Edition

4.6 out of 5 stars 9 customer reviews
ISBN-13: 978-1420073546
ISBN-10: 1420073540
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Editorial Reviews

About the Author

DOUGLAS J. PISANO is Dean of the School of Pharmacy and Professor of Pharmacy Administration, Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts, USA. Dr. Pisano received his Ph.D. in Law, Policy, and Society at Northeastern University, Boston, Massachusetts, USA. He is an active member of several professional organizations, including the American Association of Colleges of Pharmacy and the American Pharmaceutical Association. A national speaker and invited lecturer, Dr. Pisano was the recipient of the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society in 2000. He has developed several courses and programs at the Massachusetts College of Pharmacy and Health Sciences in such areas as health policy, pharmacy and drug law, and regulatory affairs. Dr. Pisano, along with coeditor Dr. David S. Mantus, is also the editor of the first edition of Informa Healthcare’s FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics.

DAVID S. MANTUS is Vice President of Regulatory Affairs and Program Management, Cubist Pharmaceuticals, Inc., Lexington; Adjunct Professor of Drug Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences, Boston; and President, C After D Inc., Boston, Massachusetts, USA. Dr. Mantus received his Ph.D. in Chemistry from Cornell University, Ithaca, New York, USA. He is an active member of the Regulatory Affairs Professional Society and the American Chemical Society and is a frequent presenter and lecturer at national conferences on biologics and biotechnology, regulatory affairs, and vaccine development. Dr. Mantus has also served as chairperson for several conferences, including "Outsourcing Regulatory Affairs" and "Vaccine Development for the 21st Century."

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Product Details

  • Hardcover: 464 pages
  • Publisher: CRC Press; 2 edition (August 11, 2008)
  • Language: English
  • ISBN-10: 1420073540
  • ISBN-13: 978-1420073546
  • Product Dimensions: 1.2 x 6.5 x 9.5 inches
  • Shipping Weight: 1.6 pounds (View shipping rates and policies)
  • Average Customer Review: 4.6 out of 5 stars  See all reviews (9 customer reviews)
  • Amazon Best Sellers Rank: #491,118 in Books (See Top 100 in Books)

Customer Reviews

Top Customer Reviews

Format: Hardcover
I used this book as part of my reference for a Couse in " Regulatory Affairs". for anybody who is interested in this field this is the most comprehensive review to date. I feel like the Author mapped the entire process from "Concept to Product" This is a very good book well researched, and a valuable resource to students and other people in the industry.
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Format: Hardcover Verified Purchase
Amazon lists a 2003 paperback as 2nd edition and this hardback 2008 as "second edition." This hardback 2008 is clearly a later edition although both are so called second editions. Maybe the other should be called first edition, or maybe the mere fact the other was a paper back printing triggers a not-very-accurate second edition logo.

Well done book. The earlier (2003/2005) edition is available on kindle but not the 2008.

BQ
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Format: Hardcover Verified Purchase
I find this book to be quite expensive. For some reason though, there are not many used copies floating around. I needed this book for a class I am taking. A lot of college coursework seems to refer to this textbook actually. While I would not say that this is light reading, there are certainly a lot of facts in this book. There are many figures too, which can be interesting in giving you a better understanding of regulatory affairs. It is very dense. The book is light weight and easy to carry. Because it is so packed with information, I do think it makes a good reference guide.

If you decided after a while that you didn't like this book, I'm sure you could easily sell this back and find a buyer. As I said before, there are not many text books on this subject out there.
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Format: Hardcover Verified Purchase
Excellent Book for regulatory affairs of drugs biologics and medical devices. I first read this book back in 2010 as part of a Master program. I keep this book on my shelf and use it as a reference source. Some of the content is starting to get aged, but overall this is still a very relevant reference source. The authors should release a new edition just bringing it up to date.
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Format: Hardcover
Even as a seasoned RA Professional, I found this book to be a invaluable resource. Simplifies a complex process!
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