Pharmaceutical law, 2006 : across the product life cycle /

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Bibliographic Details
Imprint:New York, N.Y. : Practising Law Institute, c2006.
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
Hidden Bibliographic Details
Other authors / contributors:Evans, George W.
Troy, Daniel E.
Practising Law Institute.
ISBN:140240803X
Notes:Prepared for distribution at the program of the same name held October 4-5, 2006.
"Ord #9046"-- Spine.
Includes bibliographical references.
Standard no.:9781402408038
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.