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

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

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 Compliance...read more

Cloned Animals Products in the Human Food Chain: FDA Should Protect American Consumers

Posted on August 2009 by Jennifer E.F. Butler, 2009 Graduate of the Lewis & Clark School of Law, Portland, OH

Animal cloning is “a complex process that lets one exactly copy the genetic, or inherited, traits of an animal.” In 1997, Dolly the sheep was the first animal cloned and since then &ldq...read more

61 Food and Drug Law Journal 13-44 (2006). In August 2004, President George W. Bush signed the Minor Use and Minor Species Animal Health Act of 2004 (MUMSA) into law. The purpose of this "animal o...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