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

Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the United States, where these innovative products still await F...read more

With the Medical Device Amendments of 1976, Congress granted FDA authority to regulate medical devices by implementing a risk-based regulatory framework. Several years prior to this legislation, th...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

Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard ...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

Through its premarket regulation of medical devices, FDA aims to secure device safety and effectiveness while allowing for device innovation. However, these competing objectives have proven too dif...read more

Extraterritorial Reach of the FCPA: Recommendations for U.S. Medical Device Companies with Activities in Europe

Posted on May 2011 by Erik Vollebregt, Of Counsel, Greenberg Traurig LLP, Amsterdam, The Netherlands.

65 Food and Drug Law Journal, 347-366 (2010). Traditionally medical devices companies manage business compliance with anti-corruption and anti-fraud rules in a document-oriented way that does not a...read more