Pharmaceutical law, 2006 : across the product life cycle /
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Imprint: | New York, N.Y. : Practising Law Institute, c2006. |
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Description: | 1131 p. ; 23 cm. |
Language: | English |
Series: | Intellectual property course handbook series ; no. G-878 |
Subject: | |
Format: | Print Book |
URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/6115167 |
Table of Contents:
- R&D 101: legal issues during research and development / Areta L. Kupchyk, Josephine M. Torrente
- Avoiding pitfalls in technology transfer / Joshua A. Kalkstein
- Counseling on the ethical and legal issues in biomedical research / Clinton D. Hermes, Joanna L. Bergmann
- Basics of FDA approval / David M. Fox
- A global view: U.S. and E.U. approaches to data privacy / Ruth Hill Bro
- An overview of privacy laws impacting pharmaceutical companies / Hilary M. Wandall
- Latest trends in FDA practice / Scott Gottlieb
- Securing exclusivity for your product throughout its life cycle / Gregory J. Glover
- Reforming the current enforcement environment when the legality of pharma marketing practices are in question / I. Scott Bass
- The ABC's of public and private reimbursement / Jorge Lopez, Jr.
- Preemption and the FDA preamble / Robert N. Weiner
- Counterfeit medicines outside the United States: challenges and responses / Jim Hilboldt
- Securing the global supply chain: evolving federal/state law--prescription, drug distribution, counterfeit, pedigree requirements, and the Internet / Matthew B. Van Hook
- Current trends in Hatch-Waxman patent litigation: a system still in flux / Mary W. Bourke, M. Edward Danberg
- Recent trends in patent litigation under the Hatch-Waxman Act / Steven J. Lee
- United States and European community law related to follow-on biologics / Peter O. Safir.