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 United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation se...read more

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown University partnership we feature Georgetown University Law...read more

Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act...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

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 (FDCA...read more

Second Prize, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011. While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important inform...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

This paper examines the definition of the terms "food" and "drug" as used in the Food, Drug and Cosmetic Act through the lens of biopharmed products. The paper uses the so-called "banana vaccine" a...read more