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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 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 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 more

Your Business in Court and at Federal Agencies: 2010-2011, 67 Food and Drug Law Journal, 243-292 (2012).

Posted on June 2012 by John B. Reiss, Dawn Crowder, Brian Simons, Igor Pleskov, Tiffany Davis and Patrick Nugent

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 ( 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 more

Onus of Responsibility: The Changing Responsible Corporate Office Doctrine

Posted on August 2010 by Jennifer Bragg, John Bentivoglio, and Andrew Collins, Onus of Responsibility: The Changing Responsible Corporate Officer Doctrine, 65 Food and Drug Law Journal

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 more

Protecting the Public's health Through the Application Integrity Policy

Posted on August 2010 by Paula Katz, Protecting the Public’s Health through the Application Integrity Policy, 65 Food and Drug Law Journal

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 more

American Beauty: An Analytical View of the Past and Current Effectiveness of Cosmetic Safety Regulations and Future Direction

Posted on March 2008 by "Roseann B. Termini, Attorney-at-Law, Wynnewood, PA Leah Tressler, Student, Widener University School of Law, Wynnewodd, PA"

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 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 more