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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and BiologicsFrom CRC Press
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Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
FDA Regulatory Affairs:
- provides a blueprint to the FDA and drug, biologic, and medical device development
- offers current, real-time information in a simple and concise format
- contains a chapter highlighting the new drug application (NDA) process
- discusses FDA inspection processes and enforcement options
- includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA
Three all-new chapters cover:
- clinical trial exemptions
- advisory committees
- provisions for fast track
- Sales Rank: #1500975 in eBooks
- Published on: 2008-08-11
- Released on: 2008-08-11
- Format: Kindle eBook
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."
Most helpful customer reviews
6 of 7 people found the following review helpful.
Confusing Amazon editions listing
By Bruce_in_LA
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
9 of 10 people found the following review helpful.
Meet the FDA Head on
By J Kiggs
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.
5 of 7 people found the following review helpful.
A must have for RA Professionals.
By Ariel
Even as a seasoned RA Professional, I found this book to be a invaluable resource. Simplifies a complex process!
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