The Generic Challenge

Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (second edition)

by Martin A. Voet

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Synopsis

Explains clearly and understandably the role of patents, FDA regulations of generic drugs and the Hatch Waxman Act on conventional and biological drug product development today and how directed innovation can result in enhanced care for patients while extending the commercial lives of the drugs.

The Generic Challenge is a must-read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing professionals and anyone who has an interest in the future of the leading American pharmaceutical and biotechnology industries and the high value jobs they provide. It explains clearly and understandably the role of patents, FDA regulation of generic drugs and the Hatch Waxman Act on drug development today and how improvements in innovative drug products provide enhanced benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind available on this important subject. REVIEWS
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About The Author

Martin A. Voet is a Senior Vice President and Chief Intellectual Property Counsel for a Fortune 500 pharmaceutical company with over 20 years experience in intellectual property practice. He has degrees in chemistry, business and law, coupled with practical experience in patenting pharmaceutical and biological products, litigating with generic companies over them and providing practical, hands-on planning for pharmaceutical life-cycle management.