Medicare CED: Consideration and Implications

by Kirk L. Dobbins, Of Counsel with the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.

Caught in the Rx Drug Web: Recent Proposals to Restrict Direct-to-Consumer Advertising of Restricted Devices
by Steven P. Benenson, Principal with the law firm of Porzio, Bromberg & Newman, P.C., Morristown, NJ, and team leader of the firm's Pharmaceutical Marketing & Sales Compliance and Litigation Department
and
Linda Pissott Reig, Principal with the law firm of Porzio, Bromberg & Newman, P.C., Morristown, NJ, and a member of both the firm's Pharmaceutical Marketing & Sales Compliance and Litigation Department, and Appellate Practice Group
and
Steven S. Vahidi, Associate with the law firm of Porzio, Bromberg & Newman, P.C., Morristown, NJ, and a member of the firm's Pharmaceutical Marketing & Sales Compliance and Litigation Department

United States v. Utah Medical Products, Inc.: FDA Violates Its Own QSR Policy
by Daniel G. Jarcho, Partner in the law firm of McKenna Long & Aldridge LLP, Washington, D.C.

Managing the Risks, Obligations, and Liabilities of Manufacturing and Distributing Medical Devices in Canada
by  Michelle Kisluk, Attorney in the Toronto, Canada office of Torys LLP

Assessing Medical Treatment Outcomes With Medicare Data
by Joel Slomoff, Special Consultant with the law firm of Fulbright and Jaworski, L.L.P., Washington, D.C.

Multistate Investigations of the Pharmaceutical Industry

by John J. Farmer, Partner in the law firm of Kirkpatrick & Lockhart Nicholson
Graham, LLP, Newark, NJ
and
Michael D. Ricciuti, Partner in the law firm of Kirkpatrick & Lockhart Nicholson
Graham, LLP, Boston, MA
and
Elizabeth M. Harris, Associate in the law firm of Kirkpatrick & Lockhart Nicholson
Graham, LLP, Newark, NJ

by Richard J. Leighton, Chair of the Litigation/ADR Section of Keller and Heckman LLP, Washington, D.C.

Let's Ground the Black Helicopters
by Henry I. Miller, M.D., Fellow at the Hoover Institution, Stanford University, Stanford, CA, and formerly a Food and Drug Administration official from 1979 to 1994

BioShield II: One Step Forward, One Step Back?
by Paul Ferrari, Attorney with the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.

Compliance Q&A

by John T. Bentivoglio, Partner with the law firm of King & Spalding, LLP, Washington, D.C.
and
Naoko Fujii, Healthcare Compliance Officer for Scios, Inc. and ALZA Corporation, Silicon Valley, CA

History Corner
Devices and Radiological Health at the Centennial: Panacea and Promise
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Enforcement Against Off-Label Promotion Requires a Clear Policy Pronouncement
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
Launching New Healthcare Products in the United States
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Canadian Corner
Canadian Internet Pharmacies―Are They on the Wane?
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates' Corner
Global Development of Medical Devices: Remaining Challenges
by Elizabeth D. Gobeil, Associate with Thompson Hine LLP, Atlanta, GA

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