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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.
This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharma
This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharma
This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharma
This Fourth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharm
The Generic Challenge is a must-read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing profes
