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Issue 1 : January/February 2007


Biotechnology
January/February 2007

Subscription Information

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

 



Featured Articles


Food Fights, Drug Wars, and Other Biotech Debates

by Edward L. Korwek, Ph.D., J.D., Senior Partner in the law firm
of Hogan & Hartson L.L.P., Washington , DC

Regulating Bioengineered Animals: Are We Ready?
by Robert B. Nicholas, Partner in the law firm of McDermott
Will & Emery LLP, Washington , DC
and
Valentin A. Povarchuk, Associate in the law firm of McDermott
Will & Emery LLP, Washington , DC

Regulating Transgenic Crops: Is Government Up to the Task?
by William Freese, A Science Policy Analyst with the Center for Food Safety, Washington , DC

Agricultural Biotechnology Industry: A Regulatory Wish List
by Michael J. Phillips, Ph.D., Vice President for Food and Agriculture, Science and Regulatory Affairs at the Biotechnology Industry Organization, Washington , DC
and
L. Val Giddings, Ph.D., Biotechnology Consultant and President of PrometheusAB?Advanced Expertise in U.S. and Global Biotechnology, Silver Spring , MD

Nanotechnology: FDA Seeks to Balance Safety with Cutting-Edge Technology
by Gary C. Messplay, J.D., Partner in the law firm of Hunton & Williams LLP, Washington , DC
and
John G. Moore, J.D., Ph.D., Associate in the law firm of Hunton & Williams LLP, Washington , DC
and
Colleen Heisey, J.D., M.P.H., Associate in the law firm of Hunton & Williams LLP, Washington , DC.

Project Management: A Must-Have Lubricant for Biotech Firms
by Rami Scharf, D.Sc., MBA, PMP, a Senior Director with THE WEINBERG GROUP, Washington , DC

Also In This Issue


Foreign Plaintiffs Battle to Keep Class Claims in U.S. Courts

by Stephanie A. Scharf, Ph.D., a Partner in the law firm of Jenner & Block, Chicago , IL
and
Traci M. Braun, a Partner in the law firm of Jenner & Block, Chicago , IL

Five Habits of Highly Effective Device Sponsors
by Michael E. Marcarelli, Pharm. D., Director, Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, FDA, Rockville, MD

Adverse Event Reporting: California Steps into the Fray
by Daniel A. Cody, Partner in the law firm of Reed Smith, LLP, San Francisco, CA
and
Paul W. Pitts, Associate in the law firm of Reed Smith, LLP, San Francisco, CA


Canada Seeks Uniformity with Organic Products Regulations
by Martha A. Healey, Partner in the law firm of Ogilvy Renault LLP, Ottawa, Canada
and
Alison G. FritzGerald, a Lawyer in the law firm of Ogilvy Renault LLP, Ottawa, Canada

Standard Operating Procedures: Vital to a Drug Company’s Compliance Program
by Scott S. Liebman, Associate in the law firm of Porzio, Bromberg & Newman, Morristown, NJ

Columns


Enforcement Corner

Corporate Compliance Officer―Gatekeeper or Jailbird?
by John R. Fleder, a Principal in the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

Global Corner
RNA Interference Technology Holds Out Great Promise
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner
Importation of Drugs from Canada―Latest Developments
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
The Fragmentation of Stem Cell Research Regulation
by Sarah E. Burrell, Associate with the law firm of Hunton & Williams LLP, Washington, DC


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

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