Biosimilars in Canada: New Draft Guidelines from Health Canada

by Teresa Reguly, practices intellectual property law in the law firm of Torys LLP, Toronto, Canada

and

Eileen McMahon, Partner in the law firm of Torys LLP, Toronto, Canada

The Canada Consumer Product Safety Act: The New Face of Consumer Product Regulation in Canada

by Martha A. Healey, Partner in the law firm of Ogilvy Renault LLP, Ottawa, Canada

Health Canada Aims to Finalize its Biosimilar Regulation Pathway Guidances

by Adrienne M. Blanchard, Partner with the law firm of Gowling Lafleur Henderson, Ottawa, Canada

The Canadian Chemicals Management Plan and How it Led to the World’s First Ban on Baby Bottles Containing BPA
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

and

Lee Alan Johnson, Articling student in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Yes We Can: Time for FDA Internet Drug Advertising Policy
by Arnold I. Friede, Counsel to the law firm of McDermott Will & Emery, Washington, DC

and

Robert B. Nicholas, Partner in the law firm of McDermott Will & Emery, Washington, DC

Senator Orrin Hatch Gives Keynote Address at FDLI’s 52nd Annual Conference
by Abby Foster, Managing Editor, the Food and Drug Law Institute, Washington, DC

Pharmaceutical Patents in the Age of KSR
by Patrick R. Delaney, Independent attorney practicing patent law, Alexandria, VA

A New Era of GCP Accountability: FDA Aggressively Targets
Clinical Oversight and Data Integrity
by Robert F. Church, Partner in the law firm of Hogan & Hartson LLP, San Francisco, CA

and

Ann Meeker-O’Connell, Compliance Consultant, San Francisco, CA

Accelerated FDA Review: Risks to Patent Term
by George C. Best, Partner with the law firm of Foley & Lardner LLP, Silicon Valley, CA

and

Shaun R. Snader, Associate with the law firm of Foley & Lardner LLP, Washington, DC

 

Enforcement Corner

Vindicated on Appeal―It Does Happen

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

Global Corner

The Politicization of Science

by Joseph A. Huggard, General Manager of International Operations, The Weinberg Group, Brussels, Belgium

Students Corner
Legal and Medical Implications of the Olanzapine Litigation: An Illustrative Case
by Jill Steinberg, Fellow, Glenn M. Weaver Institute of Law and Psychiatry, University of Cincinnati College of Law, Cincinnati, OH

Associates’ Corner

New Legislation Gives FTC New Role in Litigation Settlements

by Lacy L. Kolo, Associate in the law firm of Patton Boggs, McLean, VA