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

Voet, Martin A

Couverture souple

ISBN 10 : 1627346171 ISBN 13 : 9781627346177

Editeur : Brown Walker Press (FL), 2016

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.

Détails de l'édition

• Éditeur: Brown Walker Press (FL)
• Date d'édition: 2016
• Langue: anglais
• ISBN 10: 1627346171
• ISBN 13: 9781627346177
• Reliure: Broché
• Numéro d'édition: 5
• Nombre de pages: 230
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible