Diagnostics

Books & Primers

Top 20 Food and Drug Cases, 2012 & Cases to Watch 2013

April 2013

Published for the fourth consecutive year, the Top 20 Cases book, featuring analysis and discussion of the most important food and drug c...

Effective Review and Approval of Digital Promotional Tactics

March 2013

Instant Access, Purchase and Download Now by Dale Cooke Food and Drug Administration enforcement action for promotional activities remai...

Pharmaceutical and Medical Device Compliance Manual, First Edition (FDLI)

November 2012

Published by: American Health Lawyers Association (AHLA); Seton Hall; Food and Drug Law Institute (FDLI) The fight against fraud an...

Articles

Members Only ContentExecutives Should Think Twice Before Accepting Pleas ‘Relating to Fraud’: The Expansion of Exclusion Under the Park Doctrine

November 2012

Over the last three years, the Health Care Fraud Prevention and Enforcement Action Team (HEAT) has recovered over $10.2 billion in health...

DIA and FDLI Collaborate in Conference to Examine User Fees

August 2012

Food and Drug Law Institute To Hold Conference on U.S.-Brazil Food and Drug Law

August 2012

Members Only ContentGlobal Corner: The Use of Social Media by the Drug Industry in Canada, and Comparison with U.S. Laws

July 2012

by Eileen McMahon   The Internet in general, and social media in particular, is changing advertising. Drug advertising is no except...

Food & Drug Law Journal

Your Business in Court and at Federal Agencies: 2010-2011, 67 Food and Drug Law Journal, 243-292 (2012).

June 2012

This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as un...

Closing the Information Gap: Informing Better Medical Decisionmaking through the Use of Post-Market Safety and Comparative Effectiveness Information, 67 Food and Drug Law Journal, 83-102 (2012)

March 2012

Second Prize, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011. While FDA gathers vast amounts of data about prescripti...

Informal Guidance and FDA, 66 Food and Drug Law Journal, 507-550 (2011)

November 2011

This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated ...