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3 Reviews
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6 of 6 people found the following review helpful:
5.0 out of 5 stars
Meet the FDA Head on,
By J Kiggs "JKIGGS" (Boston, USA) - See all my reviews
This review is from: FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition (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.
5 of 5 people found the following review helpful:
4.0 out of 5 stars
Confusing Amazon editions listing,
By
Amazon Verified Purchase(What's this?)
This review is from: FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition (Hardcover)
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
4 of 5 people found the following review helpful:
5.0 out of 5 stars
A must have for RA Professionals.,
By
This review is from: FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition (Hardcover)
Even as a seasoned RA Professional, I found this book to be a invaluable resource. Simplifies a complex process!
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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition by Douglas J. Pisano (Hardcover - August 7, 2008)
Used & New from: $78.61
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