Generic Challenge:

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

Nonfiction, Reference & Language, Law, Patent, Trademark, & Copyright, Medical Law & Legislation, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Generic Challenge: by Martin a. Voet, Brown Walker Press (FL)
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Author: Martin a. Voet ISBN: 9781627346252
Publisher: Brown Walker Press (FL) Publication: September 1, 2016
Imprint: Brown Walker Press (FL) Language: English
Author: Martin a. Voet
ISBN: 9781627346252
Publisher: Brown Walker Press (FL)
Publication: September 1, 2016
Imprint: Brown Walker Press (FL)
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

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