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Update Magazine Issue 1

January/February 2010


FDA & Transparency
January/February 2010

Subscription Information

FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.

 

 


Featured Articles


Interview With FDLI’s New President and CEO, Susan C. Winckler
by Abby Foster, Managing Editor with FDLI, Washington, DC

FDA Transparency Initiative: Opening FDA’s “Black Box”
by Afia K. Asamoah, Special Assistant to the Principal Deputy Commissioner, Food and Drug Administration, Silver Spring, MD

Potential Loss of 180-Day Exclusivity
by J. Mark Pohl, Partner & Licensing Attorney with Pharmaceutical Patent Attorneys LLC, Morristown, NJ

The Confusing Calculus of the Benefit/Risk Ratio in Pharmaceutical
Research―Ethical Questions and Possibilities for Reform
by Mark J. Sarno, President of Vision Biotechnology Consulting, Encinitas, CA

Distinguished Service and Leadership Awards: Holiday Reception 2009
by Abby Foster, Managing Editor with FDLI, Washington, DC

The Perfect Storm: Weathering the Convergence of Federal, State and Industry Regulations Impacting Pharmaceutical Sales and Marketing Representatives
by D. Jeffrey Campbell, Managing Principal in the law firm of Porzio, Bromberg & Newman PC and President and CEO of Porzio Pharmaceutical Services, LLC both in Morristown, NJ and Sarina D. Rivera, Counsel to Hoffmann-La Roche Inc., Nutley, NJ

Columns


Canadian Corner

Commercial Agreements Among Competitors:
A New Antitrust Regime Coming to Canada in March 2010
by Brian Daley, Partner in the law firm of Ogilvy Renault, Ottawa, Ontario, Canada andRichard Wagner, Senior Partner in the law firm of Ogilvy Renault, Ottawa, Ontario, Canada

 

Global Corner

Increasing Scrutiny of Food Health Claims
by Tim Mullane, Chief Marketing Officer, The Weinberg Group, Washington, DC and Marla Scarola, Consultant to The Weinberg Group, Washington, DC


Associates’ Corner

Will USDA Require Certification for Organic Personal Care Products?
by Stacey L. Wilson, Associate in the law firm of Sidley Austin LLP, Washington, DC

 

Students Corner

Comparative Effectiveness and Personalized Medicine Frame
the U.S. Health Care Debate
by Lauren B. Beach, Third year JD and Molecular, Cellular, Developmental Biology and Genetics PhD student in the Minnesota’s Joint Degree Program in Law, Health & the Life Sciences, Minneapolis, MN

 

Enforcement Corner

But My Lawyer Told Me It Was Okay
by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

 

Membership Corner

Welcome to Membership Corner!
by Michael Sprott, Membership Manager with FDLI, Washington, DC


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

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