Issue 2 : March/April 2002
Clinical Research of New Drugs, Biologics, and Medical Devices
March/April 2002
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New Directions in Medical Research Ethics
by Bruce Jennings, Senior Research Scholar with The Hastings Center,
Garrison, NY
Financial Interests in Human Subjects ResearchAn
Overview and Update
by Jennifer Kulynych, J.D., Ph.D., Director, Division of Biomedical and
Health Sciences Research, with the Association of American Medical Colleges,
Washington, D.C.
Conflicts of Interest in Biomedical Research: Managing Legal
Risks in an Imperfect World
by Kendra Dimond, Partner in the law firm of Epstein Becker & Green,
P.C., Washington, D.C. and Robert Wanerman, Senior Associate at the
law firm of Arent Fox Kinter Plotkin & Kahn, PLLC, Washington, D.C.
Medicare Coverage of Investigational Devices
by Grant P. Bagley, M.D., Partner in the law firm of Arnold & Porter,
Washington, D.C. and M. Kay Scanlan, Associate in the law firm of Arnold
& Porter, Washington, D.C.
The Safety and Integrity of Clinical Research in Academic Medical
Centers
by Jerome A. Halperin, President and Chief Executive Officer of the
Food and Drug Law Institute, Washington, D.C.
Developing Ethics and Compliance Programs in Healthcare Organizations
by Victoria M. Wesseler, President of Ethics & Compliance Strategies,
LLC, Indianapolis, IN.
American Bioscience, Inc. v. ThompsonRushing to Judgment
in APA Litigation
by Arthur Y. Tsien, Principal in the law firm of Olsson, Frank and Weeda,
P.C., Washington, D.C. and Tish Eggleston Pahl, Associate in the law
firm of Olsson, Frank and Weeda, P.C., Washington, D.C.
AWP: Still Standing Tall in the Wake of Bayer and TAP
by Carolyn J. McElroy, Attorney in the law firm of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo, P.C., Washington, D.C. and Nell Ma'Luf, Attorney
in the law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.,
Washington, D.C.
Making History
"Only the Brave Dare Eat the Fare": The Poison Squad Revisited
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration,
Rockville, MD
Enforcement Corner
FDA's Global Reach: The Prosecution of Roussel Uclaf S.A.
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd,
Chicago, IL
Global Corner
Clinical Research Productivity
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP INC.,
Washington, D.C.
Associate's Corner
Section 11 of the Best Pharmaceuticals for Children ActA
Prelude to Reform?
by Michael H. Hinckle, Associate in the law firm of Kirkpatrick &
Lockhart, LLP, Washington, D.C.
Note: All author affiliations are current as of the date of publication of the issue.
(Note: All author affiliations are current as of the date of publication of the issue.)

