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.
Product details
Publisher : Brown Walker Press (18 March 2020)
Language : English
Paperback : 242 pages
ISBN-10 : 1627347461
ISBN-13 : 978-1627347464
Dimensions : 13.97 x 1.3 x 21.59 cm
Best Sellers Rank: 58,560 in Books (See Top 100 in Books)
2 in Patent Law
4 in Medical Law & Legislation (Books)
5 in Pharmacology Reference
Customer Reviews: 4.4
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