Members Only ContentUp to Their Old Devices? Why Differences in Drug and Device Promotion Standards Matter From An Enforcement Perspective

Posted on September 2013 by by John T. Bentivoglio, Jennifer L. Bragg and Maya P. Florence

While pharmaceutical manufacturers have been the most common target of government investigations for violations of advertising and promotion rules, prosecutors and other government enforcement offi...read more

Abstract: OIG has explicitly advised that pharmaceutical and device manufacturers are eligible for participation in the “Provider” Self Disclosure Protocol, notwithstanding it...read more

Members Only ContentDraft Guidance On Medical Device Recalls: Improvements Are Needed

Posted on August 2013 by By Jeffrey N. Gibbs, Jeffrey K. Shapiro, and Jennifer D. Newberger

On February 22, 2013, the Food and Drug Administration (FDA) issued a draft guidance aimed at a thorny issue: when to report recalls. This document, however, went further, reaching not only recalls...read more

Members Only ContentRegulatory Evolutions for Medical Devices in the EU

Posted on August 2013 by By Sarah H. Stec and Corinne Delorme

In the medical device industry, one of the largest and  most-watched regulatory overhauls is currently taking place in the European Union (“EU”). As one of the largest medical devi...read more

Members Only ContentThe Federal Regulation of Mobile Medical Apps

Posted on August 2013 by By Areta Kupchyk, Mavis Yee, and Carly B. Eisenberg, Nixon Peabody, LLP

Mobile technologies offer a platform to improve both health and healthcare delivery. It is estimated that by 2018, half of the more than 3.4 billion smartphone and tablet users will ...read more

Members Only ContentFDLI’s 56th Annual Conference FDA Alumni Association Honors Richard M. Cooper with Wiley Lecture Award

Posted on May 2013 by By Stephanie Barnes, Esq, Editor, Foods Team Member

FDLI’s 56th Annual conference hosted the presentation of the Food and Drug Administration Alumni Association’s Harvey W. Wiley Lecture Award. Richard M. Cooper currently Of Counsel at W...read more

Members Only ContentCommissioner Hamburg Gives Opening Address at FDLI’s 56th Annual Conference

Posted on May 2013 by By Stephanie Barnes, Esq., Editor, Foods Team Member

“Looking back as I approach my four year mark at the FDA, it has been an extraordinary time. Each of those years has given me a clearer perspective on FDA’s critical...read more

Members Only ContentThe European Union Medical Device Regulations: An FDLI Webinar

Posted on May 2013 by By Davina Rosen Marano, Esq., Conference Manager, Medical Products and Tobacco Team Member

On September 26, 2012, the European Commission proposed regulations, “which aim to fill the gaps in the [current] regulatory framework and respond to the claim of inadequate safety controls,&...read more

The Chinese have a saying that, roughly translated, means “four faces, eight places.”1 While the meaning is difficult to translate, it effectively means everything is connected in all d...read more

Over the last three years, the Health Care Fraud Prevention and Enforcement Action Team (HEAT) has recovered over $10.2 billion in healthcare fraud settlements, many involving pharmaceutical compan...read more