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The Generic Challenge

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

This book can be downloaded and read in iBooks on your Mac or iOS device.

Description

This Fifth 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.

The Generic Challenge
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  • $33.99
  • Available on iPhone, iPad, iPod touch, and Mac.
  • Category: Law
  • Published: Sep 07, 2016
  • Publisher: Universal Publishers
  • Seller: Universal-Publishers, Inc.
  • Print Length: 228 Pages
  • Language: English
  • Requirements: To view this book, you must have an iOS device with iBooks 1.5 or later and iOS 4.3.3 or later, or a Mac with iBooks 1.0 or later and OS X 10.9 or later.

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