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The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
| Title | The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition) |
| Writer | |
| Date | 2024-10-08 08:46:37 |
| Type | |
| Link | Listen Read |
Desciption
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. Read more
Review
Although sightly dated this book remains highly relevant.While the author has some quite strong opinions spread through this book, all are backed up by experience and expertise.With a wealth of knowledge, Voet paints a very clear picture of a complex area, bringing in enough detail to properly inform without obscuring the woods with the trees. I recommend it to those starting in the area or the older salts keen on a refresher.
