Congress Gives FDA the Power to Require Pediatric Studies
by David E. Korn, J.D., Counsel at the law firm of Arnold & Porter, L.L.P., Washington, D.C.
and John S. McInnes, M.D., J.D., Associate in the law firm of Arnold & Porter, L.L.P., Washington, D.C.

New Medicare Law Brings New Considerations for "Paragraph IV" Litigation
by Richard J. Berman, Member in the law firm of Arent Fox Kintner Plotkin & Kahn PLLC, Washington, D.C.
and Janine A. Carlan, Associate in the law firm of Arent Fox Kintner Plotkin & Kahn PLLC, Washington, D.C.

Playing by the Orange Book Listing Rules in View of Recent Hatch-Waxman Reforms
by Kristin Behrendt Kosinski, Associate in the law firm of Darby & Darby, P.C., New York, NY

Product Liability in the Pharmaceutical Industry: A Growing Role for Quantitative Analysis
by Pierre Y. Cremieux, Ph.D., Managing Principal of Analysis Group, Inc., Boston, MA
and Paul E. Greenberg, M.A., M.B.A., Managing Principal and Co-Director in the Health Economics Practice of Analysis Group, Inc., Boston, MA

Strategic Implications of FDA's Proposed Safety Reporting Requirements
by Lawrence S. Ganslaw, Associate with the law firm of Morgan, Lewis & Bockius, LLP, Washington, D.C.
and Michele L. Vockrodt, a Law Clerk with the law firm of Morgan, Lewis & Bockius, LLP, Washington, D.C.

Too Many Germs, Too Few Monkeys: The Shortage of Nonhuman Primates, Clinical Research, and Test Infrastructure
by Michael J. Hopmeier, President/CEO of Unconventional Concepts, Inc., Mary Esther, FL

Can the Public Understand a National Vaccine Campaign?
by Mark Hochhauser, Ph.D., Readability Consultant, Golden Valley, MN

Arbitration in International Pharmaceutical Joint Ventures
by Jonathan A. Schur, Partner in the law firm of Dechert LLP, Paris, France
and Emmanuelle Trombe, Associate in the law firm of Dechert LLP, Paris France

New Canadian Regulations for Natural Health Products
by Charles Boulakia, an Associate in the Intellectual Property Group of Torys LLP, Toronto, Ontario, Canada
and Cynthia Tape, an Associate in the Intellectual Property Group of Torys LLP, Toronto, Ontario, Canada

Enforcement Corner
Pharmaceutical Executive or Mafia Kingpin? Charging Decisions Can Reflect Little Difference
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd LLC, Chicago, IL

Global Corner
EU Super Directive on Food Packaging: Call for Action
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates' Corner
FDA Issues Guidance on Pharmacogenomic Data
by J. Ben Haas, Associate in the law firm of Latham & Watkins LLP, Washington, D.C.

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