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

Voet, Martin A

ISBN 10: 1627347461 ISBN 13: 9781627347464

Editore: Brown Walker Press, 2020

Lingua: Inglese

Condizione: Nuovo Brossura

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Titolo

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

Editore

Brown Walker Press

Data di pubblicazione

2020

Lingua

Inglese

ISBN 10

1627347461

ISBN 13

9781627347464

Rilegatura

Brossura

Condizione

New

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Descrizione articolo

Riassunto

This Sixth 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.

Informazioni sull?autore

Martin A. Voet was formerly Senior Vice President and Chief Intellectual Property Counsel for a Fortune 500 pharmaceutical company with over 25 years of experience. He is currently Adjunct Professor at USD School of Law and consultant to the pharma industry. He has degrees in chemistry, business and law, coupled with practical experience in patenting pharmaceutical and biological products, litigating with generic companies and providing hands-on planning for pharmaceutical product Life-cycle Management.

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