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

Voet, Martin a.

ISBN 10: 1627346171 ISBN 13: 9781627346177

Edit� par Brown Walker Press (FL), 2016

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Synopsis :

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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D�tails bibliographiques

Titre : The Generic Challenge: Understanding Patents...
�diteur : Brown Walker Press (FL)
Date d'�dition : 2016
Reliure : Paperback
Etat : Good
Etat de la jaquette : No Jacket
Edition : 5�me �dition