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 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
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
The responsible corporate officer (RCO) doctrine permits convictions of corporate officers for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), even in instances in which the corporat...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
63 Food and Drug Law Journal 257-274 (2008).
Today, more people are using cosmetics on a daily basis. What was once nothing more than a small-scale, door-to-door sales operation has become a ...read more
62 Food and Drug Law Journal 165-225 (2007).
This article traces the history of lipstick's social and legal regulation in Western seats of power, beginning in Ur circa 3,500 B.C.
Sliced in this m...read more
60 Food and Drug Law Journal 495-510 (2005).
Since President George W. Bush took office in 2000, the Food and Drug Administration (FDA) has used amicus curiae briefs in medical device and pharma...read more