Restoring Company Credibility: How to Respond to FDA's Application Integrity Policy
Marian Lee, Associate in the law firm of King & Spalding LLP, Washington, D.C.

Clinical Trials Registries & Clinical Trial Results Databases: An Update
by Erika King Lietzan, Special Counsel at the law firm of Covington & Burling, Washington, D.C.

Reporting Drug Safety Concerns: Lessons for International Pharmaceutical Companies
by Daniel J. Herling, Partner in the law firm of Duane Morris LLP, San Francisco, CA
and
Lina M. Brenner, Associate in the law firm of Duane Morris LLP, San Francisco, CA

Why Settle?
by Gregory Glass, J.D., M.B.A., Principal Member of Gregory Glass Associates, LLC, a pharmaceutical consulting firm in Downingtown, PA, and Editor of The Paragraph Four Report™.

Generic Drug Mergers: Overcoming the Antitrust Hurdles
by David A. Balto, Partner with the law firm of Robins, Kaplan, Miller & Ciresi LLP, Washington, D.C.

Patients' Right to Choose
by Henry I. Miller, M.D., Fellow at the Hoover Institution (Stanford University, Stanford, CA) and the Competitive Enterprise Institute (Washington, D.C.). He headed FDA's Office of Biotechnology from 1989 to 1993.

Merck KGaA v. Integra Life Sciences
by Elizabeth A. Galletta, Associate with the law firm of Wiggin and Dana LLP, New Haven, CT
and
William J. Speranza, Partner with the law firm of Wiggin and Dana LLP, Stamford, CT

Changing Regulatory Landscape in the EU: The Commission's Draft Medical Devices Directive Proposal
by Linda R. Horton, Partner in the law firm of Hogan and Hartson L.L.P., Brussels, Belgium
and
Matthew Giles, Associate in the law firm of Hogan and Hartson L.L.P., Brussels, Belgium

History Corner
The Scientific Underpinnings of the 1906 Pure Food and Drugs Act: Microbe Mania
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
FDA Can Compel Disclosure of a Lawyer's Notes
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 Issue of Trust
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates' Corner
Practical Tips for Settling FDA Seizures
by Farah K. Ahmed, Associate in the law firm of Collier Shannon Scott, PLLC, Washington, D.C.

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