A New Approach to Risk Disclosure in DTC Advertising
by Wayne L. Pines, President of Regulatory Services and Health Care at APCO Worldwide, in Washington, D.C.

Grounding Regulation in Behavioral Science: Strengthening FDA's Approach to DTC Risk Disclosures
by Rosemary C. Harold, Partner in the law firm of Wiley Rein & Fielding LLP, Washington, D.C.and
John F. Kamp Executive Director of the Coalition for Healthcare Communication and Of Counsel at the law firm of Wiley Rein & Fielding LLP, Washington, D.C.

Medical Device Off-Label Use and New Fraud Theories
by Howard J. Young, Partner in the Health Care Practice Group of Sonnenschein Nath & Rosenthal, LLP, Washington, D.C.and
Christopher A. Brown, Associate in the Food and Drug Law Practice Group of Sonnenschein Nath & Rosenthal, LLP, Washington, D.C.

Licensing in the Pharmaceutical Industry: Strategies and Questions Regarding Antitrust Premerger Notification
by Stephen Paul Mahinka, Partner in the Washington, D.C. office of Morgan Lewis. He is Chair of the firm's Life Sciences Practice, and Manager of its Antitrust Practice Group and
Harry T. Robins, Senior Associate in the law firm of Morgan Lewis in New York, NY

The European Directive on Clinical Trials: Is Harmony Always a Happy State?
Alison Dennis, Senior Associate in the law firm of Reed Smith LLP, London, England

Why Is FDA Attacking Injured Consumers?
by Edward J. Parr, Jr., Partner in the law firm of Ury & Moskow LLC, Washington, D.C.

FDA Regulation of Human Reproductive Cloning: A Technology in Search of a Niche
by Gail Javitt, J.D., M.P.H., Policy Analyst, Genetics and Public Policy Center, Washington, DC., and an Adjunct Professor, University of Maryland Law School, Baltimore, MD and
Kathy Hudson, Ph.D., Director, Genetics and Public Policy Center, Washington, DC, and an Associate Professor, Berman Bioethics Institute, Johns Hopkins University, Baltimore, MD

Summer of 2004: No Vacation for FDA and CBP
No Picnic for Importers of FDA-Regulated Goods
An Update on Developments at the U.S. Borders
by Deane Anne Johnson, Attorney with the law firm of Rodriguez, O'Donnell, Ross, Fuerst, Gonzalez, Williams & England, P.C., Miami, FL and
Benjamin L. England, Partner with the law firm of Rodriguez, O'Donnell, Ross, Fuerst, Gonzalez, Williams & England, P.C., Miami, FL

Go West, FDLI—Go West
by James M. Wood, Partner in the law firm of Reed Smith LLP in Oakland, CA. He also serves as Chairman of FDLI's Membership Committee ('04-'05)

History Corner
On the Bookshelf
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Sentencing Turmoil and Corporate Compliance Programs
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
Direct-to-Consumer Advertising: U.S. and European Perspectives
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates' Corner
An Organic Experience: How the National Organic Program May Violate the First Amendment
by William A. Garvin, Associate with the law firm of Buc & Beardsley, Washington, D.C.