FDA Regulation of Pharmacoeconomic Claims
by Edward M. Basile, Senior Partner, King & Spalding LLP, Washington, D.C.
and Marian Lee, third-year law student at Harvard. She will join King & Spalding LLP, Washington, D.C. in 2004.

Europe's Orphan Drug Law—Four Years and Counting
by Carol S. Curme, J.D., RAC, Senior Manager of Regulatory Affairs, Orphan Medical, Inc., Minnetonka, MN

Competition From Generic Biologics: Obstacles and Progress
by Natasha Moskvina, Attorney in the Federal Trade Commission's Bureau of Competition, Washington, D.C.
and Steve Vieux, Attorney in the Federal Trade Commission's Bureau of Competition, Washington, D.C.

Generic Drugs: A New Route to Market
by Debra Z. Anderson, intellectual property Attorney specializing in chemistry, pharmaceuticals, biotechnology, and FDA law at the law firm of Eckert Seamans Cherin & Mellott, LLC., Pittsburgh, PA

States Are Requiring Disclosure of Drug Marketing Costs
by Christopher A. Brown, Associate in the Food and Drug practice group of Sonnenschein Nath & Rosenthal LLP, Washington, D.C.

FDA's Multiple Trademarks: Over-Regulation and Regulatory Creep
by Henry I. Miller, M.D., Fellow at the Hoover Institution, Stanford University, Stanford, CA

CGMPs in the Production of Clinical Supplies
by David B. Barr, Vice President of Regulatory Consulting, AAC Consulting, Rockville, MD

Issues Raised by Follow-On Versions of Biologics
by Cathy L. Burgess, Principal in the Law Offices of Cathy L. Burgess, Washington, D.C.

OIG Releases Final Compliance Program Guidance for Pharmaceutical Manufacturers
by James M. Becker, Co-Chair of the White Collar/Government Enforcement Litigation Practice Group of Saul Ewing LLP, Philadelphia, PA
and Marci A. Love, Member of the White Collar/Government Enforcement Litigation Practice Group of Saul Ewing LLP, Philadelphia, PA

Corrective Advertising for Misleading DTC Advertisements: More to Come?
by Ivan J. Wasserman, Partner in the law firm of Collier Shannon Scott, PLLC, Washington, D.C.
and Christie L. Grymes, Associate with the law firm of Collier Shannon Scott, PLLC, Washington, D.C.

Case Alert—Cryolife v. Superior Court of Santa Cruz County
by James M. Wood, Partner in the law firm of Reed Smith Crosby Heafey LLP, Oakland, CA
and Areta Kupchyk, Of Counsel with Reed Smith LLP, Washington, D.C.
and Keith Yandell, Law Student at UCLA School of Law, Los Angeles, CA

Graduate Studies in Regulatory Affairs Writing
by Thomas E. Colonna, Ph.D., J.D., Assistant Professor, University of the Sciences, Philadelphia, PA

FDLI FY 2003 Annual Report
by Jerome A. Halperin, President and CEO, The Food and Drug Law Institute, Washington, D.C.

Making History
Documentary Debut: Elixir of Death
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Document Retention Programs: A Defense to New Obstruction of Justice Provisions
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd LLC, Chicago, IL

Global Corner
Orphan Drug Development: Gaps and Concerns
by Matthew Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associate's Corner
New Limits on the Safe Harbor Provision
by Patrick R. Delaney, intellectual property (IP) Associate, at the law firm of Piper Rudnick LLP, Washington, D.C.

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