Books > Law > Intellectual Property > Patent, Trademark & Copyright > Patent

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

Product ID: 1627346171 Condition: USED (All books in used condition)

Payflex: Pay in 4 interest-free payments of R511.25. Read the FAQ

R 2,045

includes Duties & VAT

Delivery: 10-20 working days

Ships from USA warehouse.

Secure Transaction

VISA Mastercard payflex ozow

Product Description

Condition - Very Good

The item shows wear from consistent use but remains in good condition. It may arrive with damaged packaging or be repackaged.

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

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.