The Growing Problem of Antibiotic Resistance: Medical, Legislative and Legal Implications

by Irach B. Taraporewala, Senior Consultant of Drug Development at Parexel Consulting in White Plains, NY

A Manufacturer’s Perspective:  Recent Challenges in Antibiotic Drug Approval

by Cecilia H. Burke, Senior Attorney, Regulatory at Wyeth Pharmaceuticals in Collegeville, PA

and

Geoffrey M. Levitt, Vice President and Chief Regulatory Counsel at Wyeth Pharmaceuticals in Collegeville, PA

Perspectives on Bacterial Resistance and Veterinary-Use Antibiotics

by Robert B. Nicholas, Partner in the law firm of McDermott Will & Emery in Washington, DC

and

Arnold I. Friede, Counsel in the law firm of McDermott Will & Emery in Washington, DC

Antibiotic Use in Animal Feed:  A Long-Festering Issue
by Randall C. Gordon, Vice President of Communications and Government Relations at the National Grain and Feed Association in Washington, DC

FDA in Federal Court:  The Agency’s Ten-Year Record
by Erika Lietzan, Partner in the law firm of Covington & Burling LLP in Washington, DC

and

Megan Quinlan, Associate in the law firm of Covington & Burling LLP in Washington, DC

Nanotechnology in Products and the Role Of the Federal Trade Commission
by Gergory W. Fortsch, Senior Attorney in the Dividsion of Advertising Practices in the Federal Trade Commission’s Consumer Protection Bureau in Washington, DC

Consumer Drug Advertising:  Can Congress Constitutionally Impose a Moratorium?

by Mark I. Schwartz, Associate Chief Counsel for Biologics at the Food and Drug Administration in Rockville, MD

FDA Proposes Revised CBE Rules and Reiterates Preemptive Authority
by Stephanie A. Scharf, Partner in the law firm of Schoeman Updike Kaufman & Scharf in Chicago, IL

The Changing World of Tattoos:  A Bigger Role for FDA?
by Ellen Maldonado, Attorney and Sole Practitioner in Bethesda, MD

In Wake of Recalls:  Canada Proposes Regulatory Reform
by Martha A. Healey, Partner with the law firm of Ogilvy Renault LLP in Ottowa, Ontario, Canada