How Hard Should It Be to Imprison Someone for Telling the Truth?
FDA Advertising Regulation Enforcement

by Frederick R. Ball, Partner with the Law firm of Duane Morris LLP, Chicago, IL

and

Erin M. Duffy, Associate with the Law firm of Duane Morris LLP, Philadelphia, PA

and

Nina L. Russakoff, Associate with the Law firm of Duane Morris LLP, Philadelphia, PA

Are Federal Regulators in a Funk Over Functional Foods?
Federal Regulations and Enforcement of Functional Food Claims

by Joanne S. Hawana, Associate with the law firm of Arent Fox LLP, Washington, DC

and

Brian P. Waldman, Partner with the law firm of Arent Fox LLP, Washington, DC

What’s Black and White But Not to be Read? FDA Regulation
of Tobacco Product Advertising and Marketing

by William A. McGrath, Partner in the law firm of Wiley Rein LLP, Washington, DC

and

J. Elizabeth Poole, Associate in the law firm of Wiley Rein LLP, Washington, DC

If a Movie Star Recommends it, it Must be Good, Right?
by Robert J. Klepinski, Attorney with the law firm of Fredrikson & Byron, PA, Minneapolis, MN

and

Ann M. Ladd, Attorney with the law firm of Fredrikson & Byron, PA, Minneapolis, MN

Hamburg Takes Strong Stance in Enforcement Speech at FDLI
by Abby Foster, Managing Editor, the Food and Drug Law Institute, Washington, DC

Reducing FCPA Risks for Pharmaceutical and Medical Device Companies
Through Cost-Effective Compliance Strategies
by Matt T. Morley, Partner in the Law firm of K&L Gates LLP, Washington, DC

and

Suzan Onel, Partner in the Law firm of K&L Gates LLP, Washington, DC

The Future of an Organic Personal Care Product Standard
by Carrie Dooher, Attorney with the Law firm of Kleinfeld Kaplan & Becker, Washington, DC

180-Day Exclusivity: Forfeiture Decisions by FDA
by Naomi Halpern, Partner in the law firm of Frommer, Lawrence & Haug, LLP,
Washington, DC

Health Information Technology for Economic and Clinical Health Act (HITECH Act):
Breach Notification Requirements and Their Impact on the Pharmaceutical Industry
by James M. Beslity, Senior Counsel, Head of Global Privacy and Records Management at Bristol-Myers Squibb Company, Princeton, NJ

and

Guilherme M. Costa, Associate in the law firm of Drinker Biddle & Reath LLP, Washington, DC

 

Enforcement Corner

The Park Criminal Liability Doctrine: Is it Dead or is it Awakening?

by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

Canadian Corner
Progressive Licensing―New Opportunities for the Development
of Orphan Drugs in Canada?

by Brian Daley, Partner in the Law firm of Ogilvy Renault, Montreal, Quebec, Canada

and

Richard Cheung, Associate in the Law firm of Ogilvy Renault, Toronto, Ontario, Canada

Students Corner
The Food Safety Enhancement Act: Adjusting Food Safety Procedures
for the 21st Century

by Christine Arena, second year Law student at Penn State University Dickinson School of Law and Research Assistant in the school’s Agricultural Law Resource and Reference Center, State College, PA

Associates’ Corner

How Will the Family Smoking Prevention and Tobacco Control Act Impact the Electronic Cigarette Industry?

by Azim Chowdhury, Associate at Duane Morris LLP, Baltimore, MD