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

Voet, Martin A.

ISBN 10: 1612337287 / ISBN 13: 9781612337289

Published by Brown Walker Pr, 2013

About this Item

A copy that has been read, but remains in clean condition. Shows signs of wear and previous use. May include writing/highlighting, library labels, stickers, shelf/handling wear, damages to pages/spine/binding/cover, and other defects. May not include the dust jacket or supplementary material (toys, access code, dvds, etc). A portion of your purchase benefits nonprofits! - STOCK PHOTO, ITEM DETAILS (PUBLICATION YEAR, FORMAT, ETC) & OTHER INFO MAY BE INACCURATE. PRODUCT'S ACTUAL EDITION, ITEM DETAILS & FORMAT MAY DIFFER FROM WHAT IS SHOWN. INFO/PHOTOS PROVIDED UPON REQUEST.

Seller Inventory # 584R0H0000J3_ns

Bibliographic Details

• Title: The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management
• Publisher: Brown Walker Pr
• Publication Date: 2013
• Language: English
• ISBN 10: 1612337287
• ISBN 13: 9781612337289
• Binding: paperback
• Edition: 4th Edition
• Condition: Good
• Weight: 0.6 pounds

About this title

Synopsis

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.