Clinical Trials of Off-Label Drug Use: A Regulatory Minefield
by Carol A. Pratt, Ph.D., J.D., of Counsel with the law firm of Preston Gates & Ellis, LLP, Portland, OR

Access to Experimental Drugs: A New Constitutional Right?
by Ralph F. Hall, a Visiting Associate Professor of Law at the University of Minnesota Law School and Counsel to Baker & Daniels LLP, Indianapolis, IN
and
Colleen M. Roberts, Associate with Baker & Daniels LLP, Indianapolis, IN

Clinical Research Risks and the Importance of Life-Cycle Safety Assessments
by Nancy A. Lass, M.D., FAAP, FCP, holds appointments in the Department of Medicine and on the Committee on Clinical Pharmacology, University of Chicago, Chicago, IL
and
James T. O’Donnell, Pham.D., MS, FCP, ABCP, FACN, Associate Professor of Pharmacology at Rush Medical College, Rush University Medical Center, Chicago, IL, and President of Pharmaconsultant Inc., Barrington, IL

Phase IV Commitments: What Works and What Does Not
by Robert I. Roth, M.D., Ph.D., Medical Director, THE WEINBERG GROUP, San Francisco, CA

Solving the Recruitment Riddle: How Manufacturers Can Facilitate Subject Recruitment
by Jennifer S. Geetter, Associate with the law firm of McDermott Will & Emery LLP, Washington, DC

EU Implements Key Changes for Clinical Trials – What It Means for U.S. Companies
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

FDA’s Comments Herald New Strength for Preemption Defense
Stephanie A. Scharf, Ph.D., Partner with Jenner & Block LLP, Chicago, IL
and
M. Joseph Winebrenner, Third-year student at Columbia University School of Law, and a 2006 summer intern at Jenner & Block LLP, Chicago, IL

Canada Proposes 8 Years of Data Protection for Innovative Drugs
by Kristin Wall, Associate in the law firm of Ogilvy Renault LLP, Toronto, Ontario, Canada
and
Jason C. Markwell, Partner in the law firm of Ogilvy Renault LLP, Toronto, Ontario, Canada

Food Contact Notification System Survives Budget Cuts
by Jerome H. Heckman, A founding partner of Keller and Heckman LLP, Washington, DC

History Corner
The Elusive Concept of Pure Food and the Problem with Milk
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Companies Trapped Between a Rock and a Hard Place
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
EU Seeks Bigger Role in Global Research Arena
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner
Clinical Trials and Natural Health Products
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
Patent Holders Getting Scant Help Under Doctrine of Equivalents
by David I. Berl, Associate with the law firm of Williams & Connolly LLP, Washington, DC

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