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Issue 6 : November/December 2006



The Electronic Challenge

November/December 2006

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

 

 

 

Feature Articles


Electronic Tracking of Prescription Drugs: Why Is it Taking So Long?

by Jill B. Deal, Partner at the law firm of Venable LLP, Washington, DC
and
Ronald E. Quirk, Jr., Of Counsel at the law firm of Venable LLP, Washington, DC

Part 11 and Electronic Signatures: Once Again, an Idea Whose Time Has Gone
by Frederick Razzaghi, Director, Technical Affairs at Consumer Healthcare Products Association, Washington, DC

Electronic Submission of Product Information: Liability Risks for Industry
by Charles Lister, Partner in the law firm of Covington & Burling, London, England

Going Paperless: Electronic Medical Records Come with Own Set of Risks
by John B. Reiss, Ph.D., Partner and Chairman of the Health Law Department in the law firm of Saul Ewing LLP, Philadelphia, PA

Also In This Issue


Ephedra and the Tenth Court: FDA’s Powers Under DSHEA Clarified

by Scott Bass, heads the International Food and Drug Law Practice at Sidley Austin LLP, Washington, DC

Using FOIA to Supplement Discovery in Private Civil Litigation
by Julia C. Tierney, Associate with the law firm of Arent Fox PLLC, Washington, DC

The Next Enforcement Target: Your Company’s Compliance Office
by Ralph F. Hall, Visiting Associate Professor of Law at the University of Minnesota Law School and Counsel to Baker & Daniels, Indianapolis, IN and Washington, DC

Falling Short: Final Guidance on Coverage with Evidence Development
by Kirk L. Dobbins, Of Counsel with the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

Roundtable Discussion: Importance of Causation Analysis in Mass Tort Cases
by Paul E. Greenberg, Moderator, Managing Principal of Analysis Group, Inc., Boston, MA
and
George J. Lykos, Panelist, Chief Legal Officer with the Bayer Corporation, Pittsburgh, PA
and
Sara J. Gourley, Panelist, Partner with the law firm of Sidley Austin LLP, Chicago, IL
and
Colleen T. Davies, Panelist, Partner with the law firm of Reed Smith LLP, Oakland, CA

Columns


History Corner

Implementing the 1906 Act: No Easy Task for the Inspectors
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Aggressive Enforcement Policies Are Drawing Rebuke
by Steven M. Kowal, Chair of the White Collar Criminal Defense Group at the law firm of Bell, Boyd & Lloyd LLC, Chicago, IL

Global Corner
Protecting Privacy of Patient Information
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner
Understanding the Complex Rules Governing Chemicals
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
Research Biological Materials―Who Owns Them?
by Yi-Kang Hu, Ph.D., J.D., Associate at Preston Gates & Ellis, LLP, Portland, OR

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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