Publications

Showing Publications By: Erika Lietzan

Biotechnology and the Law, editor, with Eileen Smith Ewing, Hugh Butler Wellons, Robert F. Copple, Willian Neal Wofford

(ABA, 2007)

Issues in the Interpretation of 180-Day Exclusivity

62 FOOD AND DRUG LAW JOURNAL 49 (2007)

Learned Intermediary Doctrine: Required by Law?

LAW360 (July 17, 2007)

Advisory Committees at FDA: The Hinchey Amendment and ‘Conflict of Interest’ Waivers

39 JOURNAL OF HEALTH LAW 415 (2006)

Clinical Trial Registries and Clinical Trial Results Databases

FDLI UPDATE (Sept 2005)

2004 Update: 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

59 FOOD AND DRUG LAW JOURNAL 459 (2004).

A Brief History of 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

59 FOOD AND DRUG LAW JOURNAL 287 (2004).

The Importance of the Court Decision in Pearson v. Shalala to the Marketing of Food and Dietary Supplements in the United States

in REGULATION OF FUNCTIONAL FOODS AND NUTRACEUTICALS: A GLOBAL PERSPECTIVE, (Blackwell Press and Institute of Food Technologists Press, 2004)

The Authority of a Court to Order Disgorgement for Violations of the Current Good Manufacturing Practices Requirement of the Federal Food, Drug, and Cosmetic Act

58 FOOD AND DRUG LAW JOURNAL 149 (2003)

FDA in Federal Court: Statistics on the Agency’s Record in Recent Years

FDLI UPDATE (July/Aug 2002)