Opening Pandora's Box: Unregulated On-Line Pharmacy Operations and Legalized Drug Importation
by Linda Pissott Reig, Principal with Porzio, Bromberg & Newman, P.C., Morristown, NJ
and George Benaur,Associate with Porzio, Bromberg & Newman, P.C., New York, NY

Drug Safety: New Legal/Regulatory Approaches
by Lawrence S. Ganslaw, Associate in the Food and Drug Administration/Healthcare Regulation practice of the law firm of Morgan, Lewis & Bockius, LLP, Washington, D.C.

Rx Drug and Food Products Liability Cases: A Mutual Learning Experience?
by Lori G. Cohen, Shareholder in the Litigation, Products Liability, and Life Sciences practices of the law firm of Greenberg Traurig, LLP, Atlanta, GA
and
Christina Wang, Associate in the Litigation practice of the law firm of Greenberg Traurig, LLP, Atlanta, GA

California's Compliance Program Mandate: Turning the OIG Guidance and PhRMA Code Into Law
by Robert A. Freeman, U.S. Compliance Officer and Compliance Counsel for Serono, Inc., Rockland, MA

Streamlining Clinical Trial Agreement Negotiations
by Norman M. Goldfarb, Chairman of MAGI and Managing Partner of First Clinical Research, Palo Alto, CA

When Are Clinical Trial Risks Too Risky?
by Mark Hochhauser, Ph.D., Psychologist who researches, writes, and consults on document readability and writing style, Golden Valley, MN

New Canadian Consumer Advertising Guidelines for Marketed Health Products
by Ingrid VanderElst, Intellectual Property Department, Torys LLP, Toronto, Canada
and Tanya Baytor, Intellectual Property Department, Torys LLP, Toronto, Canada

New in the EU: Draft Human Tissue-Engineered Products Regulation
by Linda R. Horton, Partner in the law firm of Hogan and Hartson L.L.P., Brussels, Belgium
and
J. Héctor Armengod, Associate in the law firm of Hogan and Hartson L.L.P., Brussels, Belgium

 

Postmarketing Requirements for Medical Devices
by William M. Janssen, Litigation Partner and Chair of the Life Sciences Practices at the law firm of Saul Ewing LLP , Philadelphia, PA
and
Royce W. Smith, Litigation Associate and a Member of the Life Sciences Practices group at Saul Ewing LLP, Philadelphia, PA

Practicability of Follow-On Biologics: An Overview
by Robert C. Price, Associate with the law firm of Connor, Weber & Oberlies, P.C., Paoli, PA

 

History Corner
The Era of Eclectic Medicine
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Global Corner
What Is Next for the Regulation of Biogenerics?
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates' Corner
Applying Basic Privacy Principles to the Use of RFID
by Jennifer J. Daniels, Associate with the law firm of Blank Rome LLP, Philadelphia, PA

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