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

Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Framework, 69 Food and Drug Law Journal, 237-272 (2014)

Posted on April 2014 by Diane E. Hoffmann, Claire M. Fraser, Frank Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few yea...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

Honorable Mention, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011. Obesity is one of the most contentious issues facing the United States today. Some researchers warn of an obesi...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

Data Quality and Transparency in the Dietary Supplement Industry

Posted on August 2010 by A. Dallas Wait, Ph.D. Data Quality and Transparency in the Dietary Supplement Industry, 65 Food and Drug Law Journal

Reliable and defensible data quality underpins the value and validity of decisions made by dietary supplement manufacturers, consumers, and regulatory investigators.  Over the past few years, ...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

Emerging Product Categories in India: A Regulatory View

Posted on November 2009 by Maruthi Prasad Palthur, Director of Regulatory Affairs and Quality at Indigene Pharmaceuticals, Inc., Westborough, MA

64 Food and Drug Law Journal 677-692 (2009). The world market for functional foods, nutraceuticals, and dietetic products has been expanding and is driven by demographic, economic, and social trend...read more