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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics 2nd Edition
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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."
Top Customer Reviews
Well done book. The earlier (2003/2005) edition is available on kindle but not the 2008.
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.
Most Recent Customer Reviews
Good source for fundamentals organized to facilitate use and provide detailed information. Needs reviewPublished 19 months ago by Dennis Trent
It helped me in my preparation for my RAPS certification testing.Published 24 months ago by Timothy R. Placek
I bought the kindle version, I am not really feeling it, I would have rather bought the hardcopy of the book, but great book.Published on January 11, 2014 by Sherase Coleman