The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (second edition) - Softcover

Voet, Martin A.

Softcover

ISBN 10: 1599424444 ISBN 13: 9781599424446

Publisher: Brown Walker Press, 2008

Synopsis

Explains clearly and understandably the role of patents, FDA regulations of generic drugs and the Hatch Waxman Act on conventional and biological drug product development today and how directed innovation can result in enhanced care for patients while extending the commercial lives of the drugs. The Generic Challenge is a must-read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing professionals and anyone who has an interest in the future of the leading American pharmaceutical and biotechnology industries and the high value jobs they provide. It explains clearly and understandably the role of patents, FDA regulation of generic drugs and the Hatch Waxman Act on drug development today and how improvements in innovative drug products provide enhanced 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.

Edition details

• Publisher: Brown Walker Press
• Publication date: 2008
• ISBN 10: 1599424444
• ISBN 13: 9781599424446
• Binding: Paperback
• Language: English
• Edition number: 2
• Number of pages: 184