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Issue 4 : July/August 2002


Update 2002, Issue 4: Perspectives on Regulation of Technologies

 

Perspectives on Regulation
of Technologies

July/August 2002

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

 

 

 

Faeture Articles


Food Irradiation: Regulating an Old Technology in a New Way

by Jeffrey T. Barach, Ph.D., Vice President of Special Projects, National Food Processors Association, Washington, D.C.

Viewing Biotech's Future Through Multiple Lenses
by Hugh Grant, Chief Operating Officer of the Monsanto Company, St. Louis, MO

Labeling and Traceability of GMOs in the Food Sector in the EU
by Nicole Coutrelis, Attorney in the law firm of Coutrelis & Associes, Paris, France

The Draft International Convention on Telemedicine and Telehealth
by Joseph P. McMenamin, M.D., Partner in the law firm of McGuire Woods LLP, Richmond, VA

Gene Therapy Forces Public Health Community to "Know Thyself"
by Marc J. Scheineson, Partner in the law firm of Reed Smith LLP, Washington, DC, and a former FDA Associate Commissioner

Hospital Outpatient New Technology Pass-Through Payments: Companies Need to Review
by John B. Reiss, Ph.D., J.D., Partner and Chair of the Health Law Department in the law firm of Saul Ewing, LLP, Philadelphia, PA

More Risk at FDA
by Kenneth Jensen, Principal Regulatory Manager at Medtronic, Minneapolis, MN

FDA Challenges to Pharmaceutical Company Control of Product Lifecycle Management
by Stephen Paul Mahinka, Partner in the law firm of Morgan Lewis, Washington, DC
and Kathleen M. Sanzo, Partner in the law firm of Morgan Lewis, Washington, DC

 

Also In This Issue


Evaluating a Healthcare Product for Acquisition, In-Licensing, Joint Venture, or Marketing

by Beth Silverstein, M.S., RAC, Director of SciLucent, LLC, Lovettsville, VA
and Carl G. Osborne, D.V.M., Managing Director of SciLucent, LLC, Lovettsville, VA
and Thomas L. McMahon, Senior Manager of SciLucent, LLC, Lovettsville, VA

Human Subject Research: The HIPPA Issues
by Karen Owen Dunlop, Partner in the law firm of Sidley Austin Brown and Wood, Chicago, IL and Laura J. Cole, Associate in the law firm of Sidley Austin Brown and Wood, Chicago, IL

FDA in Federal Court: Statistics on the Agency's Record in Recent Years
by Erika King, Associate in the law firm of Covington & Burling, Washington, DC
and Elizabeth Martell Walsh, Associate in the law firm of Covington & Burling, Washington, DC

Antitrust and Regulatory Filings: The Buspirone Patent Litigation
by David Balto, Partner in the law firm of White & Case LLP, Washington, DC
and Jeremy O. Evans, Associate in the law firm of White & Case LLP,
Washington, DC

 

Columns


Making History

A History Primer on Bioterrorism: Part I
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Internet Drug Sales: A Potential Prescription for Indictment
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd, LLC, Chicago, IL

Global Corner
Global Organization and New Technologies
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP, INC., Washington, DC

Associates' Corner
Functional Beverages: A Category Ahead of Its Time
by Emily Marden, Associate with the law firm of Sidley Austin Brown & Wood,
New York, NY

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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