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

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 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’s proposed graphic warning labels for cigarette packages have been scrutinized for potentially violating the First Amendment’s free speech clause.  This article addresses the 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: 2011-2012, 68 Food and Drug Law Journal, 1‑52 (2013).

Posted on March 2013 by John B. Reiss, Dawn Crowder, Brittany McCabe, Marisa DeFeo, Marta Rifin and Meghan Talbot

FDA transparency effort continued, including the Secretary’s adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of more

Implementation of the Family Smoking Prevention and Tobacco Control Act is resulting in FDA establishing a comprehensive tobacco policy, which includes a scientific evidence based process to more

The Presidential Commission for the Study of Bioethical Issues suggested in its report “Research Across Borders: Proceedings of the International Research Panel of the Presidential 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

Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009 with the aim of reducing tobacco-related illnesses and deaths by curbing tobacco's appeal to and use by children and more