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

Voet, Martin A.

ISBN 10: 1612337287 / ISBN 13: 9781612337289

Editore: Brown Walker Pr, 2013

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Dati bibliografici

• Titolo: The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management
• Editore: Brown Walker Pr
• Data di pubblicazione: 2013
• Lingua: Inglese
• ISBN 10: 1612337287
• ISBN 13: 9781612337289
• Rilegatura: paperback
• Edizione: quarta edizione
• Condizione: Good
• Peso: 0,6 libbre

Descrizione articolo

Riassunto

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.