The Generic Challenge: Understanding Patents, Fda And Pharmaceutical Life-cycle Management
Editorial Reviews
Book Description
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. * Chapters 1-2 cover patents generally and patent enforcement and infringement * Chapter 3 covers pharmaceutical, biological and medical device patents * Chapters 4-5 cover FDA and drug product exclusivities * Chapter 6 covers the Hatch Waxman Act and recent Medicare Act Amendments * Chapter 7 puts it all together with Pharmaceutical Life-Cycle Management
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Is the pharmaceutical industry really evil? Is importing drugs from Canada good policy? Fighting Generics is a must read for lawyers, researchers, marketers, managers and executives and anyone who has an interest in the future of the American pharmaceutical and biotechnology industries and the high tech jobs they provide. This book is about insuring that there will be important new and innovative life-saving drugs in the future by maintaining the proper balance between innovative and generic drugs today. It explains in a clear and understandable way how the patent laws, FDA regulation of generic drugs, the Hatch Waxman Act and research on improvements may be used to enhance the lives of innovative pharmaceutical products. Learn all about patents, FDA and generic drugs explained in simple, easy to understand language, with a few jokes tossed in for fun. There is simply no other book of this kind available on this important subject.
--This text refers to the
Digital
edition.
The Generic Challenge: Understanding Patents, Fda And Pharmaceutical Life-cycle Management
The Generic Challenge: Understanding Patents, Fda And Pharmaceutical Life-cycle Management,Martin A. Voet,Brown Walker Press (FL),1581124309,General,Law,Legal Reference / Law Profession
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