Generic Pharmaceutical Patent and FDA Law
Author : Shashank Upadhye
Publisher :
Page : 1008 pages
File Size : 43,55 MB
Release : 2012
Category : Generic drugs
ISBN : 9780314615978
Author : Shashank Upadhye
Publisher :
Page : 1008 pages
File Size : 43,55 MB
Release : 2012
Category : Generic drugs
ISBN : 9780314615978
Author : Shashank Upadhye
Publisher :
Page : 643 pages
File Size : 38,79 MB
Release : 2008
Category : Generic drugs
ISBN : 9780314991447
Author : Martin A. Voet
Publisher : BrownWalker Press
Page : 240 pages
File Size : 29,92 MB
Release : 2020-05-01
Category : Law
ISBN : 1627347461
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.
Author :
Publisher : DIANE Publishing
Page : 129 pages
File Size : 39,18 MB
Release : 2002
Category :
ISBN : 1428951938
Author : Martin A. Voet
Publisher : Brown Walker Press (FL)
Page : 230 pages
File Size : 33,17 MB
Release : 2016-09-07
Category : Drugs
ISBN : 9781627346177
This 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 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.
Author : United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice
Publisher :
Page : 196 pages
File Size : 45,43 MB
Release : 1989
Category : Drugs
ISBN :
Author : Martin A. Voet
Publisher : Brown Walker Press
Page : 0 pages
File Size : 49,68 MB
Release : 2013-11
Category : Drugs
ISBN : 9781612337289
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.
Author : Martin A. Voet
Publisher :
Page : 202 pages
File Size : 47,44 MB
Release : 2016
Category :
ISBN : 9781627346191
This 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 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.
Author : United States. Congress. Senate. Committee on the Judiciary
Publisher :
Page : 310 pages
File Size : 42,43 MB
Release : 1997
Category : Law
ISBN :
Author : Martin A. Voet
Publisher : Brown Walker Press
Page : 174 pages
File Size : 25,88 MB
Release : 2011
Category : Law
ISBN : 9781599425764
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. REVIEWS "I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents." Dennis Crouch, Associate Professor of Law, University of Missouri, Editor of Patently-O.com "An extraordinary book full of practical, strategic information on the interaction of drug creation, law and regulatory approval. Provides a perceptive and insightful analysis of patent and regulatory laws affecting drug development. A must-read for anyone associated with a pharmaceutical company, from mangers and CEOs to CFOs and regulatory professionals, The Generic Challenge will guide readers through the many legal and business pitfalls that arise at every stage of their business." Stephen R. Albainy-Jenei, Attorney at Law, Editor of PatentBaristas.com