Members Only ContentUpdate Magazine March/April 2015

Posted on March 2015 by FDLI

Featured Food Labeling Consultations and Modernization in Canada By Martha A. Healey  HIPAA and MOBILE HEALTH APPS: What developers need to know about app user privacy By Cindy J. Alvarado...read more

Members Only ContentUpdate Magazine January / February 2015

Posted on January 2015 by FDLI

Table of Contents Featured Risky Business – On the Trial of Tainted Dietary Supplements by Jason Humbert  Between Two Evolving Regulatory Systems: Importing US-Made Foods into Chin...read more

Members Only ContentUpdate Magazine November/December 2014

Posted on November 2014 by FDLI

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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On February 22, 2013, the Food and Drug Administration (FDA) issued a draft guidance aimed at a thorny issue: when to report recalls.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