The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Sixth Edition) - Paperback

FormatBook

Language English

ISBN-13 / SKU 9781627347464

About this item

by Martin a. Voet (Author)

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.

Number of Pages: 242

Dimensions: 0.51 x 8.5 x 5.5 IN

Illustrated: Yes

Publication Date: March 18, 2020

$62.13

Temporarily out of stock.