AbstractThis 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.
[W]ho would benefit from a book toeing the line of enabling appreciation without going into too much detail? .... [T]he book is perfectly suited for introductory courses related the pharmaceutical industry and for most any pharmaceutical company employee who needs a better understanding of the industry within which they operate. 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.
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About the AuthorMartin 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 email@example.com.
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