Generic And Innovator Drugs: A Guide to Fda Approval Requirements

Beers, partner in a DC law firm, details FDA regulatory law (for a decade through 1985 he was Assoc. Chief Counsel for Drugs at FDA) . In some 800 pages he maps the challenging route to approval with careful attention to his specialty, the Hatch-Waxman provisions. With a focus on the FDA approval of generic drugs, the work covers the topic from all angles, from the many requirements of the approval process itself (including several different types of applications) to delaying approval of competitive products, to FDA fraud policy and accelerated approvals. It covers: changes to the Federal Food, Drug and Cosmetic Act made as part of the 2003 Medicare Prescription Drug Act; abbreviated new drug applications; 505(b) (2) new drug applications (previously called 'Paper NDAs') ; approval of biologic drugs; the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; the Food and Drug Administration Modernization Act of 1997; FDA Export Reform and Enhancement Act of 1996; the Drug Price Competition and Patent Restoration Act of 1984. The appendices comprise over two-thirds of the whole dealing with statutes, discussions from the Federal Register, and letters.