Pharmaceutical companies use social media such as Facebook and Twitter more and more to advertise their products. Advertising of medicinal products especially in social media is a critical issue 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 more

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA’s promulgation of graphic images violated tobacco companies’ First Amendment rights. While the tobacco 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 more

Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulating products containing nanoscale materials for several more

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to 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 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 ( more

Biological drug products are poised to overtake traditional pharmaceuticals as the best selling products in the pharmaceutical industry. Accordingly, both innovator and generic drug companies have more

Sorrell v. IMS Health, Inc. (“IMS Health”), a remarkable health care case with resounding First Amendment and economic repercussions, features the clashing interests of the State of more