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

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

62 Food and Drug Law Journal 617-652 (2007). Genetic testing has become an integral part of health care. With tests available to diagnose, treat, or predict more than 1400 diseases, obtaining an ...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

Coordination of Federal Regulation and Payment for New Diagnostic Tests: A Proposed New Approach

Posted on May 2002 by Michele Schoonmaker, Grant P. Bagley & M. Kay Scanlan

Issue: 57 Food and Drug Law Journal 195-204 (2002). Technical advances in healthcare are clinically useful only if they are available, yet availability is typically slowed until the technology is...read more