Tissue Banking:
FDA Expands Authority in Growing Industry
by Caroline A. Hartill, Chief Scientific Officer and Vice President of Quality Assurance and Regulatory Affiars at Regeneration Technologies, Inc. in Alachua, FL

FDA’s Regulatory Scheme for Human Tissue: A Brief Overview
by Jeffrey K Shapiro, Director in the law firm of Hyman, Phelps & McNamara P.C., Washington, DC

and

Brian J. Wesoloski, Associate in the law firm of Hyman, Phelps & McNamara P.C., Washington, DC

Current Good Tissue Practices:
The Core Requirements when Donating Human Tissue
by Randy Prebula, Director of Regulatory Sciences at the law firm of Hogan & Hartson LLP, Washington, DC

The Uniform Anatomical Gift Act:
Presumption in Favor of Donation Remains
by Kate Beardsley, Partner with the law firm of Buc & Beardsley in Washington, DC

and

Carmen M. Shepard, Partner with the law firm of Buc & Beardsley in Washington, DC

and

Deborah L. Livornese, Of Counsel with the law firm of Buc & Beardsley in Washington, DC

A New Regulatory Regime for Tissue Engineered Products in Europe
by Peter Bogaert, Partner in the Brussels, Belgium-based offices of Covington & Burling LLP

and

David Van Passel, Associate in the Brussels, Belgium-based offices of Covington & Burling LLP

Patent Applications for Drug Makers:
The Changing Environment Requires a New Approach
by Estelle J. Tsevdos, intellectual property attorney and Partner in the New York City office of the law firm of Hunton & Williams LLP

and

by Donna M. Praiss, intellectual property attorney and Partner in the New York City office of the law firm of Hunton & Williams LLP

The Role of Epidemiology in Drug Safety Litigations
by Mei Sheng Duh, Vice President at Analysis Group, Boston, MA

and

Paul E. Greenberg, Managing Principal and Co-director of the Health Care practice at Analysis Group, Boston, MA

and

Jennifer R. Weiner, Associate at Analysis Group, Boston, MA

EU Data Protection Laws: Implications for Clinical Trials
by Bret Cohen, Associate in the Environemental, Health and Safety Group at Willkie Farr & Gallagher LLP, Washington, DC

and

Sara Woldin, former Legal Assistant at Willkie Farr & Gallagher LLP, Washington, DC and current PhD sudent in the History Department at Yale University

Managing Stress:
How I Learned to Enjoy Air Travel, Root Canals and FDA Inspections
by Christopher Hagenbush, Partner with the law firm of Patton Boggs LLP, Washington, DC

Enforcement Corner
The Pursuit of Civil Money Penalties―
An Important Weapon in FDA’s Enforcement Arsenal
by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

Global Corner
The Current State of Global Tissue Regulation
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner
Trans Fat Regulation in Canada: Voluntary Compliance…for Now
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
Dubious Antitrust Claims Can Harm Innovation in Drug Industry
by Amy Miner, Associate with the law firm of Drinker Biddle & Reath LLP

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