The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Sixth Edition)
- ISBN-10
- 1627347461
- ISBN-13
- 9781627347464
- Series
- The Generic Challenge
- Category
- Law
- Pages
- 240
- Language
- English
- Published
- 2020-05-01
- Publisher
- BrownWalker Press
- Author
- Martin A. Voet
Description
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.
Get the book
Other editions
-
- 2016-09-07
- 230 pages
- Paperback
- Brown Walker Press (FL)
-
- 2013-11
- - pages
- Paperback
- Brown Walker Press
-
- 2011
- 174 pages
- Paperback
- Brown Walker Press
Similar books
-
The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management
By Martin A. VoetThis 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 ...
-
Generic drug entry prior to patent expiration an FTC study
Generic drug entry prior to patent expiration an FTC study
-
Bottle of Lies: The Inside Story of the Generic Drug Boom
By Katherine EbanMeanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global.
-
How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry
How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry
-
Generic and Innovator Drugs: A Guide to FDA Approval Requirements
By Donald O. Beers, Kurt R. KarstCompletely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process.
-
Anda Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators
By Kenneth L. Dorsney"Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law, this in-depth resource balances perspectives from both name-brand drug patentees and generic drug ...
-
Crs Report for Congress: Pharmaceutical Patent Litigation Settlements
By John R. Thomas, Congressional Research Service: The LibrBrand-name firms that wish to enforce their patents against generic competitors must commence litigation in the federal courts.
-
Drug Wars: How Big Pharma Raises Prices and Keeps Generics off the Market
By Robin Feldman, Evan FrondorfIn this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest.
-
INNOVATION, ECONOMIC DEVELOPMENT, AND INTELLECTUAL PROPERTY IN INDIA AND
By Kung-Chung Liu, Uday S. RacherlaThis open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China.
-
Pharmaceutical Chartbook: Second Edition
By Abraham G Hartzema, C Daniel MullinsIn this new edition of Pharmaceutical Chartbook, readers get a bird?s-eye view of the major trends in the pharmaceutical industry.