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Issue 4 : July/August 2007



Emergency Preparedness

July/August 2007

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

 

 

Featured Articles


The Bioterrorism Act after 5 Years―Is it Working?

by Leslie Alan Glick, Partner in the law firm of Porter, Wright, Morris & Arthur, Washington, DC

BioShield II―A Step in the Right Direction?
by Paul L. Ferrari, Principal in the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

Pandemic Influenza: Companies Should Plan for the Worst and Assess Legal Exposure
by Margaret C. “Peggy” Binzer, Partner in the law firm of McKenna Long and Aldridge LLP, Washington, DC

and

Ted Shoneck, Managing Director for Tunnell Consulting’s Government Services Group, King of Prussia, PA

Liability Protection: Shielding Vaccine Makers from Litigation
by Gregory W. Fortsch, Attorney with the law firm of Manatt, Phelps & Phillips, LLP, Washington, DC

Pet Food Recall―Exposing Holes in U.S. Food Safety Defenses
by Robert B. Nicholas, Partner at McDermott Will & Emery, LLP, Washington, DC

Also In This Issue


Follow-On Biologics: Non-Patent Market Exclusivity in the U.S. and EU

by Deborah M. Shelton, Special Counsel in the FDA Practice Group in the law firm of Sheppard Mulin Ricter & Hampton LLP, Washington, DC

and

Melinda Friend, Director of Legal Affairs at Triskel Integrated Services, Geneva, Switzerland

Marshalling An Effective Defense Amid Wave of Food Contamination Litigation
by Antony B. Klapper, Partner with the law firm of ReedSmith LLP, Washington, DC

and

Marilyn A. Moberg, Partner with the law firm of ReedSmith LLP, Los angeles, CA

and

John M. McIntyre, Partner with the law firm of ReedSmith LLP, Pittsburgh, PA

and

Elizabeth A. Ransom, Attorney with the law firm of ReedSmith LLP, Washington, DC

Lessons Learned: Establishing an Effective Compliance Program for Clinical Research
by Michael M. Mustokoff, Partner at the international law firm of Duane Morris LLP, Philadelphia, PA

and

David A. Degnan, Associate at the international law firm of Duane Morris LLP, Philadelphia, PA

Splitting Hairs: A Case Study of Substantial Equivalence Determination
by Edward M. Basile, Senior Partner with the law firm of King & Spalding LLP, Washington, DC

and

Laurie A. Clarke, Partner with the law firm of King & Spalding LLP, Washington, DC

and

Elizabeth T. Valentine, Associate with the law firm of King & Spalding LLP, Washington, DC

Columns


Enforcement Corner
Diet and Weight-Loss Ads―Fat Targets for FTC Action
by John R. Fleder, a Principal in the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

Global Corner
New EU Law on Chemicals is Expected to Have Broad Impact
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
Supreme Court’s KSR Decision May Impact Drug Patents
by Benjamin P. Kota, Associate with the law firm of Greenblum & Bernstein, P.L.C, Reston, VA

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

 

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

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