New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients
"This is an excellent primer on the drug development process that importantly stresses the inter-relationship of studies in each part of the process.  I will not only use this book in my course on drug discovery but will also recommend it to faculty interested in translational research."  --Anthony Giordano, PhD  Assistant Dean of Research and Business Development, Office of Research and Director, Experimental Therapeutics, Feist-Weiller Cancer Center Louisiana State University, Shreveport, LA"Dr. Friedhoff has been a very effective consultant to our firm, and we have profited greatly from his insights.  His book, New Drugs, is an eye-opening, inside look at an enormous and very complex sector of the economy, presented in a concise, well-written, and accessible manner.  Highly recommended."   --Oscar Schafer, Member of "Barron's Roundtable"      and Managing Partner of OSS Capital Management, NYC"As the author makes clear, he has learned from many years of drug development.  NEW DRUGS really does reveal insider insights that cannot be found in other volumes. This book has been selected for The First Clinical Research Bookshelf."             --Norman M. Goldfarb Managing Director of First Clinical Research LLC