The Generic Challenge

by Martin A. Voet

Overview

This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

Product Details

BN ID:	2940163009282
Publisher:	Universal-Publishers, Inc.
Publication date:	04/29/2020
Sold by:	Barnes & Noble
Format:	eBook
File size:	5 MB

About the Author

Martin A. Voet was formerly Senior Vice President and Chief Intellectual Property Counsel for a Fortune 500 pharmaceutical company with over 25 years of experience. He is currently Adjunct Professor at USD School of Law and consultant to the pharma industry. He has degrees in chemistry, business and law, coupled with practical experience in patenting pharmaceutical and biological products, litigating with generic companies and providing hands-on planning for pharmaceutical product Life-cycle Management.
He can be reached at .

Editorial Reviews

With the potent introduction provided by this book the reader will be better equipped to decide how and when to seek help from experienced experts with knowledge of patents, FDA regulations, and other refined specialies within the pharmaceutical industry.
https://www.drugpatentwatch.com/blog/the-generic-challenge/

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