The Benefits of Incorporating Quality Systems in the Drug GMP Regulation
by Timothy R. Wells, President, Wells and Associates, Derwood, MD

Quality Systems in the Medical Device Industry
by David M. Link, Executive Vice President of the EXPERTech Division, Boston Healthcare Associates, Boston, MA

FDA's Electronic Records and Electronic Signatures Rule: Structuring a Risk-Based Approach
by Kate Duffy Mazan, Attorney with Kate Duffy Mazan, Esq., PLLC, McLean, VA

Medical Product Bar Codes: Scanning the Future of Patient Safety
by Richard M. Johnson, Director of the Center of Excellence-Drugs in the Corporate Regulatory Quality Science organization at Abbott Laboratories, Abbott Park, IL

Medical Device Manufacturers and the "Creative" Use of the False Claims Act
by Howard J. Young, a fraud and abuse Attorney in the law firm of Sonnenschein, Nath & Rosenthal, LLP, Washington, D.C. Previously, he was a Deputy Branch Chief with the DHHS Office of Inspector General and Lisa A. Estrada, a fraud and abuse Attorney in the law firm of Sonnenschein, Nath & Rosenthal, LLP, Washington, D.C.

Medical Devices: Going Home
by Mary Weick-Brady, Deputy Division Director, Division of Surveillance Systems, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD

A Medicare Prescription Drug Program: Lessons From the Medical Device Industry
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. He also authored the book Bringing Your Medical Device to Market, published by FDLI in 2001.

The SAFETY Act: Implications for the Pharmaceutical Industry
by James M. Wood, member of the Product Liability Practice Group and a Partner in the law firm of Reed Smith Crosby Heafey LLP, Oakland, CA
and Steven J. Boranian, member of the Northern California Trial Group and a Partner in the law firm of Reed Smith Crosby Heafey LLP, San Francisco, CA

Competitive Concerns and Price Transparency in the PBM Market
by David A. Balto, Partner in the law firm of White & Case, LLP, Washington, D.C. and is the former Director of Policy in the Bureau of Competition of the Federal Trade Commission.

Canada's New Natural Health Products Regulations
by Gordon S. Jepson, Partner in the law firm of Deeth Williams Wall LLP, Toronto, Canada

FDA Import Operations: A 35-Year Retrospective
by Marvin A. Blumberg, Senior Consultant, AAC Consulting Group, Rockville, MD

Making History
100th Anniversary of the 1906 Pure Food and Drugs Act
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Managing Public Perception During a High-Profile Investigation
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd, Chicago, IL

Global Corner
Risk-Based cGMPs—Whose Risk Is It, Anyway?
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP, Washington, D.C.

Associate's Corner
Dietary Supplements: Ionizing Radiation, Kosher, and Halal Certifications
by Joseph W. LaPlume, Attorney in the law firm of Goulston & Storrs, P.C., Boston, MA

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