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: 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 prescription...read 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 charac...read 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 Commission...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

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 ad...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

The Family Smoking Prevention and Tobacco Control Act: An Overview

Posted on November 2009 by Ricardo Carvajal, Of Counsel with the law firm of Hyman, Phelps & McNamara, PC, Washington, DC

64 Food and Drug Law Journal 717-732 (2009). Signed into law on June 22, 2009, the Family Smoking Prevention and Tobacco Control Act provides FDA with regulatory authority over virtually every aspe...read more

FDA Regulation of Tobacco: Blessing or Curse for FDA Professionals?

Posted on August 2009 by James T. O’Reilly, Professor, College of Law, University of Cincinnati, Cincinnati, OH

64 Food and Drug Law Journal, 459-472 (2009).   Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now “regulate” very gently, with its ...read more