Making Mandatory Compliance Programs Work
by Andrew E. Reisman, Senior Advisor, Ethics, Compliance and Governance, LRN, Los Angeles, CA

Benefit-Risk Management for Medical Products
by R. William Soller, Ph.D., Clinical Professor of Pharmacy at the University of California, San Francisco, and Executive Director, Center for Consumer Self Care, San Francisco, CA

Making Risk Communications and Education More Effective
by Gary Slatko, M.D., M.B.A., Head, Products and Services for ParagonRx, Wilmington, DE
Nanci Mayer-Mihalski, Learning Systems Leader at ParagonRx, Wilmington, DE
and Marc Deluca, Process Technician at ParagonRx, Wilmington, DE

Risk Communication: Are You Safe?
by Garry A. Courtney, Senior Regulatory Affairs Specialist with a U.S. manufacturer of medical devices

Risk Communication of Medical Device Failures
by Marta L. Villarraga, Ph.D., Senior Managing Engineer, Exponent, Inc., Philadelphia, PA
Ephrat Most, Sc.D., an Engineer, Exponent, Inc., Philadelphia, PA
and Steven M. Kurtz, Ph.D., Principal Engineer and Director, Exponent, Inc., Philadelphia, PA

Risk Communication: Consent Delayed Is Consent Denied
by Mark Hochhauser, Ph.D., a psychologist who researches, writes, and consults on document readability and writing style, Golden Valley, MN

Stem Cell Research Initiatives: Filling the Funding and Materials Gaps
by Robert Roth, M.D., Ph.D., Medical Director for THE WEINBERG GROUP, INC., Washington, D.C.

The Critical Role and Legality of Pharmacy Compounding in the Modern Marketplace
by Howard M. Hoffmann, Senior Litigation Partner and Trial Attorney in the law firm of Duane Morris LLP, Chicago, IL

Comparable Alternatives, Cost Effectiveness, and Clinical Trial Data:
The Medicare Prescription Drug Bill Changes the Reimbursement Landscape
by Michael M. Gaba, Partner in the office of Holland & Knight LLP, Washington, D.C., where he co-chairs both the National Health Law and Food & Drug Teams

State Common Law Claims Regarding Medical Devices Subject to PMAs Are Preempted by the FDCA Says FDA
by John B. Reiss, Ph.D., J.D., Partner and Chair of the Health Law Department in the law firm of Saul Ewing LLP, Philadelphia, PA

The Clinical Aspects of Claim Substantiation: Inclusion/Exclusion Criteria, Screening, and Baseline Evaluations in Clinical Trials
by Ioana G. Carabin, M.D., President and Medical Director of Women Health Sciences Institute (a nonprofit (501(c)(3)) organization), Vero Beach, FL

Making History
FDA’s Yearly Project Plan: “Its Principal Virtue Being an Obviation of Vagueness”
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
False Statements During an Internal Investigation Can Become a Federal Crime
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
Risk Communication
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates’ Corner
FDA Tests Its Power to Regulate Dietary Supplements
by Andrea D. Rose, Associate with the law firm of Crowell & Moring LLP, Washington, D.C.

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