Generic and Innovator Drugs: A Guide to FDA Approval Requirements

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Aspen Publishers, 2004 - Law - 462 pages
Generic and Innovator Drugs: A Guide to FDA Approval Requirements explains each step of the approval process, including the often-disputed Hatch-Waxman provisions. With a focus on the FDA approval of generic drugs, this one-of-a-kind reference and practice tool 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. This new Sixth Edition completely covers changes to the Federal Food, Drug and Cosmetic Act made as part of the 2003 Medicare Prescription Drug Act. Extensive updates include coverage of: abbreviated new drug applications - 505(b)(2) new drug applications (previously called 'Paper NDAs') - delaying approval on competing products - and FDA approval of biologic drugs. The book interprets and applies expert guidance on: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - The Food and Drug Administration Modernization Act of 1997 - The FDA Export Reform and Enhancement Act of 1996 - and The Drug Price Competition and Patent Restoration Act of 1984. In addition, a comprehensive Appendix and extensive Internet references provide direct access to the essential source documents in this complicated area of the law.

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About the author (2004)

Beers is a partner in the Washington law firm of Arnold & Porter, where he specializes in FDA regulatory law.

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