How Risk Management Is Implemented at FDA
by Lester M. Crawford, D.V.M., Ph.D., Deputy Commissioner, Food and Drug Administration, Rockville, MD and Scott Gottlieb, M.D., Senior Advisor for Medical Technology, Food and Drug Administration, Rockville, MD and Susan M. Bond, M.S., Special Assistant to the Deputy Commissioner, Food and Drug Administration, Rockville, MD

Risk, Precaution, and Regulation
by John D. Graham, Ph.D., Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President

Risk Management—ISO 14971: The World Standard for Medical Devices
by Alfred M. Dolan, a Samuel Lunenfeld Professor in Clinical Engineering, University of Toronto, Canada, and Convenor of the IEC/ISO Joint Working Group on Risk Management.

Telescope Replaces Microscope: FDA's Cultural Shift on Risk Issues
by James T. O'Reilly, Professor, University of Cincinnati College of Law, Cincinnati, OH

Web-Based Pharmacovigilance: A Survey
by Richard H. Parrish, II, Ph.D., R.Ph., Assistant Professor, Pharmacy Practice, Bernard J. Dunn School of Pharmacy, Shenandoah University, Winchester, VA
and Thomas M. Ellington, Pharm.D., Associate Professor, Pharmacy Practice, and Director, Drug Information Division, Bernard J. Dunn School of Pharmacy, Shenandoah University, Winchester, VA

Risk Management in Food Safety: The Waiting Game
by Caroline Smith DeWaal, J.D., Director of Food Safety, Center for Science in the Public Interest, Washington, D.C.

Dietary Supplements: Risks and Management
by Michael J. O'Flaherty, Principal in the law firm of Olsson, Frank and Weeda, P.C., Washington, D.C. and Sharon D. Brooks, Associate in the law firm of Olsson, Frank and Weeda, P.C., Washington, D.C.

The Conflict Between the First Amendment and FDA's Regulation of "Commercial Speech
by John M. Desiderio, Of Counsel to Jacobs deBrauwere LLP, New York, NY

New Horizons: NAD Asserts Jurisdiction Over Rx Advertising
by Emily Marden, Attorney in the Food and Drug Practice group at Sidley Austin Brown & Wood LLP, New York, NY and Diane C. McEnroe, Attorney in the Food and Drug Practice group at Sidley Austin Brown & Wood LLP, New York, NY

The Fate of Pharming
by John Barlow Weiner, Attorney with the law firm of Ropes & Gray, Washington, D.C.

GMO Regulatory Developments in the European Union
by Roger Chadwick, Advisor with the Liberal/ELDR Group in the European Parliament, Brussels, Belgium

FDA's Interpretation of Clinical Superiority Under the Orphan Drug Regulations
by Julie Taitsman, M.D., J.D., Associate in the law firm of Arnold & Porter, Washington, D.C. and Matthew Eisenstein, J.D., Associate in the law firm of Arnold & Porter, Washington, D.C.

New Canadian Labeling Requirements for Most Prepackaged Foods
by Joanna Jazairi, Student/Associate at the office of Torys LLP, Toronto, Ontario, Canada

Making History
Sugar: A Cautionary Tale
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
The Far-Reaching Impact of DoJ's Corporate Fraud Task Force
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd, Chicago, IL

Global Corner
Product Safety Update Report—A Risk Management Tool for Everyone
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP, Washington, D.C.

Associate's Corner
FDA Addresses the Problem of Antibiotic-Resistant Infections
by Margaret R. Emmert, Associate with the law firm Ice Miller, Indianapolis, IN

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