The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fourth Edition) - Softcover

Voet, Martin A.

 
9781612337289: The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fourth Edition)

Inhaltsangabe

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.

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Reseña del editor

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.

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Weitere beliebte Ausgaben desselben Titels

9781581124309: The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management

Vorgestellte Ausgabe

ISBN 10:  1581124309 ISBN 13:  9781581124309
Verlag: Brown Walker Press, 2005
Softcover