Should GMPs Mean "Give More to Plaintiffs"?
Impacts of Treating GMP Violations as Manufacturing Defects
by James T. O'Reilly, Professor at the University of Cincinnati College of Law, Cincinnati, OH

GMPs and Product Liability: A Canadian Perspective on Drugs
by Marcy McKee, Associate with the law firm of Blake, Cassels & Graydon LLP, Toronto, Ontario, Canada
and Cindy Yan, Associate with the law firm of Blake, Cassels & Graydon LLP, Toronto, Ontario, Canada

Administrative Claims Data: A Valuable Tool in Pharmaceutical Litigation
by Paul E. Greenberg, M.A., M.B.A., Co-Director of the Health Economics Practice with Analysis Group, Inc., Boston, MA
and Howard G. Birnbaum , Ph.D., Co-Director of the Health Economics Practice with Analysis Group, Inc., Boston, MA

Medical Monitoring
by Sean P. Wajert, Partner in the law firm of Dechert LLP, Philadelphia, PA

Enforcement and Litigation—Strategies and Initiatives
by Cathy L. Burgess, Senior Counsel, Regulatory Affairs, with the American Red Cross, Washington, D.C. At the time this article was written, she was a Principal in the Law Offices of Cathy L. Burgess, Washington, D.C.

"Fraud on the FDA" Liability?
by James M. Beck, Of Counsel in the law firm of Dechert LLP, Philadelphia, PA

Lessons From the ImClone Affair: Demystifying Drug Development for the Investing Public
by Benjamin Hron, Associate in the law firm of Kirkpatrick & Lockhart, Boston, MA

Dr. McClellan's Prescription for FDA
by Henry I. Miller, M.D., Fellow at the Hoover Institution, Stanford University, Stanford, CA. From 1979 to 1994, he was an official at FDA; during the period 1989-1993, he was Director of the Office of Biotechnology.

Off-Label Dissemination: What the Constitution Giveth, Are the OIG and DOJ Taking Away?
by Mark E. DuVal, Esq., Partner in the law firm of Klepinski & DuVal, P.A., Minneapolis, MN

Making History
"God, Motherhood, and the Flag"—Implementing the First Pharmaceutical GMP Regulations
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Charging Decisions: Will the Government Overplay Its Hand?
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd LLC, Chicago, IL

Global Corner
Drug Counterfeiting—A Worldwide Concern
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates' Corner
FDA Implements the Bioterrorism Act
Food Registration, Notice Requirements, and Exemptions for Food Contact Substances
by Michael A. Galano, Associate in the law firm of Holland & Knight LLP, Washington, D.C.

Note: All author affiliations are current as of the date of publication of the issue.