FDA’s Budget Shortfall: Bad News for Public and Regulated Industry
by William K. Hubbard, Consultant. A former Associate Commissioner for Policy and Planning with the Food and Drug Administration.

Curing the Funding Ills at FDA: Three Prescriptions
by Stuart M. Pape, Managing Partner in the law firm of Patton Boggs LLP, Washington, DC
and
Kevin M. O’Neill, Partner in the law firm of Patton Boggs LLP, Washington, DC

Stakes Are High in Drug and Device User Fee Tug-of-War
by Marc J. Scheineson, Partner in the law firm of Alston and Bird, Washington, DC

FDA’s Funding Battle: Improved Communications May Emerge
by Wayne L. Pines, President, Regulatory Services & Healthcare, APCO Worldwide, Washington, DC

How Safe Is Safe? Dietary Supplements and the Reasonable Expectation of Certainty
by James C. Griffiths, Ph.D., Director of Toxicology for The Burdock Group, Vero Beach, FL and Washington, DC

Radio Frequency Medical Devices: At the Intersection of FCC, FDA and Privacy Concerns
by Linda D. Bentley, Member of the healthcare practice of Mintz Levin Cohn Ferris Glovsky and Popeo PC, Boston, MA
and
Russell H. Fox, Member in the communications sections of Mintz Levin Cohn Ferris Glovsky and Popeo PC, Washington, DC

CMS Proposes Expanded Use of Part D Data: Will It Stay Confidential?
by Kirk L. Dobbins, Of Counsel with the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

New Challenges in Canada over Drug Pricing and Reimbursement
by Wayne D. Critchley, Partner in the law firm of Gowling Lafleur Henderson LLP, Ottawa, Canada
and
Martin W. Mason, Partner in the law firm of Gowling Lafleur Henderson LLP, Ottawa, Canada

Follow-On Biologics: EU Takes Lead in Approval Standards
by Peter Bogaert, Partner in the law firm of Covington & Burling LLP, Brussels, Belgium

History Corner
Statins ― A Success Story Involving FDA, Academia and Industry
by Suzanne White Junod, Ph.D.

Global Corner
Critical Path to Personalized Medicine ― Who Will Lead the Way?
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Enforcement Corner
Are Food and Drug Lawyers ‘Real’ Lawyers?
by John R. Fleder, a Principal in the law firm of Hyman, Phelps & McNamara, P.C., Washington, DC

Canadian Corner
Drug Name Confusion: Canada’s Policy on ‘Look-Alike, Sound-Alike’ Products
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
Adverse Event Reporting: New Law Targets OTC Drugs and Supplements
by Vincent Amatrudo, Associate with the law firm of Buc & Beardsley, Washington, DC