Your Business in Court
by John B. Reiss, Ph.D., Partner & Chair of the Health Law Department, Saul Ewing LLP, Philadelphia, PA and William M. Janssen, Litigation Partner & Chair of the Life Sciences Group, Saul Ewing LLP, Philadelphia, PA

Machiavelli, Excellent Cadavers, and Altruism ... Resisting Self-Interest and Preserving the Corporation
by Michael J. Hensley, M.D., President of Hensley & Pilc, Inc., Chapel Hill, NC

State Laws and Clinical Trials: Liability Risks Associated With Failure to Comply With State Requirements
by John C. Serio, Attorney with Brown Rudnick LLP, Boston, MA and
Jerome B. Tichner, Jr., Attorney with Brown Rudnick LLP, Boston, MA

Mass Tort Litigation: The Ounce-of-Prevention Approach
by Jane F. Thorpe, Partner in the Products Liability practice group at Alston & Bird, LLP, Atlanta, GA and
David Venderbush, Of Counsel in the Products Liability practice group at Alston & Bird, LLP, New York, NY and
Scott A. Elder, Associate in the Products Liability practice group at Alston & Bird, LLP in Atlanta, GA

Fraud Allegations Prompt Call for Mandatory Publication of Clinical Trial Results
by Steven P. Benenson, Principal with the law firm of Porzio, Bromberg & Newman, P.C., Morristown, NJ and
Elizabeth A. Brophy, Associate with the law firm of Porzio, Bromberg & Newman, P.C., Morristown, NJ

*Enforcement Dialogue on "Off-Label" Use of Products: Correspondence and Commentary
by Mark A. DuVal, Managing Partner and Vice President of Klepinski & DuVal, P.A., Minneapolis, MN

*This article is comprised of three parts: a letter from the Department of Justice (DOJ) to the Washington Legal Foundation (WLF), WLF's letter in response, and the author's commentary in reaction to both. The letters are reprinted here from text provided to Update by the WLF legal department.

California's Improper Reach on Prescription Product Marketing? A Disincentive to Develop Life-Saving Therapies
by James M. Wood, Partner in the law firm of Reed Smith LLP, Oakland, CA

Dying for Regulatory Reform
by Henry Miller, M.D., fellow at the Hoover Institution (Stanford University, Stanford, CA) and the Competitive Enterprise Institute (Washington, DC), was an FDA official from 1979 to 1994

The Clinical Aspects of Claim Substantiation: The Concept of Cause-and-Effect
by Ioana Carabin, M.D., President and Medical Director of Women's Health Sciences Institute (a nonprofit (501(c)(3) organization), Vero Beach, FL

Key Changes in European Union Legislation on Generics
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

Proposed Changes to Canada's Patented Medicines (Notice of Compliance) Regulations and Food and Drug Regulations—Mixed News for Innovative Drug Companies
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada and
Andy Radhakant, Associate in the law firm of Ogilvy Renault in Toronto, Canada

Compliance Q&A Corner
by John T. Bentivoglio, Partner with the law firm of King & Spalding LLP,
Washington, D.C. and
Naoko Fujii, Senior Director of Health Care Compliance for Scios, Inc., Fremont, CA

History Corner
Popular Images of Food Adulteration
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Fraud and Abuse Investigations: Time for Some Restraint
by Steven M. Kowal, Chair of the White Collar Criminal Defense Group at the law firm of Bell, Boyd & Lloyd LLC, Chicago, IL

Global Corner
Protecting Your Business Here and Abroad
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.