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The Generic Challenge : Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fourth Edition) - Martin A. Voet

The Generic Challenge

Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fourth Edition)

eBook

Published: 24th January 2014
Format: PDF
$38.95
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This Fourth 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 available on this important subject.

ISBN: 9781612337296
ISBN-10: 1612337295
Format: PDF
Language: English
Published: 24th January 2014