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

Voet, Martin A

 
9781627346177: The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
Tapa blanda
ISBN 10: 1627346171 ISBN 13: 9781627346177
Editorial: Brown Walker Press, 2016

Sinopsis

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.

"Sinopsis" puede pertenecer a otra edición de este libro.

Críticas

I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents. -DENNIS CROUCH, Associate Professor of Law, University of Missouri School of Law, Editor of Patently-O.com An extraordinary book full of practical, strategic information on the interaction of drug creation, law and regulatory approval. Provides a perceptive and insightful analysis of patent and regulatory laws affecting drug development. A must-read for anyone associated with a pharmaceutical company, from managers and CEOs to CFOs and regulatory professionals, The Generic Challenge will guide readers through the many legal and business pitfalls that arise at every stage of their business. -STEPHEN R. ALBAINY-JENEI, Attorney at Law, Editor of PatentBaristas.com

Reseña del editor

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.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
Brown Walker Press
Año de publicación
2016
Idioma
Inglés
ISBN 10 
1627346171
ISBN 13 
9781627346177
Encuadernación
Tapa blanda
Número de edición
5
Número de páginas
230
Contacto del fabricante
no disponible
Persona responsable
no disponible

Otras ediciones populares con el mismo título

9781627346757: The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)

Edición Destacada

ISBN 10:  1627346759 ISBN 13:  9781627346757
Editorial: Brown Walker Press (FL), 2016
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