This Article describes and evaluates two elements of the FDA’s recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency’s FOIA b...read more
The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few yea...read more
The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in...read more
FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court’s analysis in Sackett v...read more
This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA...read more
Honorable Mention, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011.
Obesity is one of the most contentious issues facing the United States today. Some researchers warn of an obesi...read more
This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as ...read more
Reliable and defensible data quality underpins the value and validity of decisions made by dietary supplement manufacturers, consumers, and regulatory investigators. Over the past few years, ...read more
FDA's recent use of the Application Integrity Policy (AIP), most notably in the ongoing Ranbaxy matter, has created interest in the policy. The article discusses actions CDER's Office of Compliance...read more
64 Food and Drug Law Journal 677-692 (2009).
The world market for functional foods, nutraceuticals, and dietetic products has been expanding and is driven by demographic, economic, and social trend...read more