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Issue 2 : March/April 2002

 

Update 2002, Issue 2: Clinical Research of New Drugs, Biologics, and Medical Devices

 

 

 

Clinical Research of New Drugs, Biologics, and Medical Devices

March/April 2002

Subscription Information
FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.

 

 

 

Feature Articles


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.

 

Also In This Issue


Developing Ethics and Compliance Programs in Healthcare Organizations

by Victoria M. Wesseler, President of Ethics & Compliance Strategies, LLC, Indianapolis, IN.

American Bioscience, Inc. v. Thompson—Rushing 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.

 

Columns


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.)

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