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The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Sixth Edition)
Paperback
ISBN13: 9781627347464
Publisher: Brown Walker Press
Published: Mar 18 2020
Pages: 242
Weight: 0.63
Height: 0.51 Width: 5.50 Depth: 8.50
Language: English
This 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.
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