Issue 4 : July/August 2006
Drug Approval & Process:
FDA Policy & Practice
July/August 2006
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Rigorous New Standards for Patient Reported Outcome Studies
by Marc J. Scheineson, Partner in the Washington, D.C. office of Alston + Bird and a former Food and Drug Administration Associate Commissioner and Sharon D. Brooks, Senior Associate in the Washington, D.C. office of Alston + Bird
Drug Labels: The New Orange Book
by Terry G. Mahn, Managing Principal, Fish & Richardson P.C., Washington, D.C., and head of the company's Regulatory Practice Group
Confusion in Drug and Health Product Names: Health Canada's New "Look-Alike, Sound-Alike" Policy
by Ingrid VanderElst, practices law in the Toronto office of Torys LLP
and
Lisa Allegro, student-at-law at Torys LLP
Risk Management Programs: A Supplement to the Controlled Substances Act
Sidney H. Schnoll, M.D., Ph.D., Vice President, Risk Management Services, Pinney Associates, Inc., Bethesda, MD
and
Michelle D. Ertischek, Associate, Pinney Associates, Inc., Bethesda, MD
and
Jack E. Henningfield, Ph.D., Vice President, Research and Health Policy, Pinney Associates, Inc., Bethesda, MD
Nutragenomics: Nexus of Value for the Nutraceutical Industry
by Jeffrey A. McKinney, J.D., Ph.D., Intellectual Property Attorney in the San Francisco and Del Mar offices of Sheppard Mullin Richter & Hampton LLP
Does It Matter Whether the Best Is REALLY the Best? Advertising Claims in Canada
by Martha A. Healey, Partner with the law firm of Ogilvy Renault LLP in Ottawa, Ontario, Canada
and
Penny S. Bonner, Partner with the law firm of Ogilvy Renault LLP in Toronto, Ontario, Canada
History Corner
Foods for Special Dietary Use
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD
Enforcement Corner
The Government Has Added Fuel to the Qui Tam Explosion
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
The International Drug Approval Process
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.
Canadian Corner
Compounding of Drugs in Canada: Whose Province Is It?
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada
Associates' Corner
Handling FDA Inspections: A Litigator's Perspective
by Daniel L. Russell Jr., Associate in the law firm of McKenna Long & Aldridge LLP, Washington, D.C.
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.)