Gearing Up for the Big Battle: The Politics and Policy of PDUFA
by Daniel A. Kracov, Partner in the law firm of Arnold & Porter LLP, Washington, DC
and
Meghan D. Taira, Health Policy Manager in the law firm of Arnold & Porter LLP, Washington, DC

Weaning FDA, Congress and Industry from User Fees
by Ralph F. Hall, Visiting Associate Professor of Law at the University of Minnesota. He also serves as counsel to the law firm of Baker & Daniels, Indianapolis, IN and Washington, DC
and
Robert J. Berlin, a joint-degree student in law and public health at the University of Minnesota

The Challenge for Congress: Bringing Food Safety Into the 21st Century
by Ken Kelly, Staff Attorney, Food Safety with the Center for Science in the Public Interest (CSPI), Washington, DC

An Industry Perspective: The New Congress and its Impact on Big Pharma
by Kay Holcombe, Senior Policy Advisor; Government Relations, Genzyme Corporation, Washington, DC

Biotech Industry Looks for Commitment to Innovation
by James C. Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), Washington, DC

Therapeutic Orphans No More: FDA and Congress Encourage Study of Drugs in Children
by Julian P. Klazkin, Senior Attorney with the U.S. Government Accountability Office (GAO), Washington, DC

State Marketing Disclosure Laws: The Unintended Consequences
by Sarina D. Rivera, Associate with the law firm of Porzio, Bromberg & Newman, P.C., Morristown, NJ and New York, NY

Canada's Natural Health Products Regime: An Update
by Tanya Baytor, Associate in the Intellectual Property Department of the law firm of Torys LLP, Toronto, Canada

Punitive Damages in Tort Litigation: How Much is Too Much?
by Stephanie A. Scharf, Partner in the law firm of Schoeman, Updike, Kaufman & Scharf, Chicago, IL

Enforcement Corner
Who Decides Your Fate in FDA Enforcement Matters?
by John R. Fleder, a Principal in the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

Global Corner
Strides Made in Global Harmonization of Drug Approval
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner
Quebec’s New Pharmaceutical Policy ― An Overview
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates' Corner
DNA Patents: More than Someone ‘Owning Your Genes’
by Nicole M. Tepe, Associate with the law firm of Frost Brown Todd LLC, Cincinnati, OH

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