Update Nov Dec 2013 - (Page 7)

PREPAREDNESS letter from the editor www.fdli.org Letter the Food Editor Published by From the and Drug Law Institute D ecember is holiday time and FDLI is excited to be hosting its Annual Holiday and Leadership Awards The Bioterrorism Act after 5drug law community. Reception for its members in the food and Years - Is it Working? BioShield II - A Step in the Right Direction? But, at FDLI, December is also a time for one of our most important annual events, the Enforcement, demic Influenza: Companies Should Plan for the December and Assess Legal Exposure Litigation and Compliance Conference, which is ticketed for Worst 10-11 this year. Liabilitywe'll continue our tradition of including presentations that our attendees always seem to appreciate Protection: Shielding Vaccine Makers from Litigation This year Pet Food Recall - Exposing Holes alsoU.S. Food Safety Defenses participants. as well as some new features that, hopefully, will in be music to the ears of our listeners and So, we hope you'll join us again - or for the first time - at Compliance Central on Day 1 to find out first-hand what FDA center compliance officials have on their docket for 2014; get an inside look at interagency enforcement; tune into the latest developments in criminal and civil enforcement, both domestically and internationally; and discover what you really need to know about the process of litigation and settlement. But, for the first time, you'll also hear the Eric M. Blumberg Memorial Lecture (check out the column by President & CEO Susan Winckler), and you'll find out what "What Keeps Compliance Officers (and Legal Counsel) Up at Night. In the meantime, check out our four feature articles on enforcement: Joshua Axelrod's piece on self-enforcement concludes that "at a company with a culture of credibility, noncompliance is apparent and not tolerated because the culture is such that employees are committed to doing business the right way." Take a close look at the article on FDA's final guidance on mobile medical apps by Daniela Pirvu. The agency has carved out a category of mobile apps that meet the definition of a medical device but will be subject to enforcement discretion because they pose little or no risk to patients. Don't be surprised to see more articles on mobile apps in Update in the next few years. You'll also want to read carefully the article by Kim Schmid, Katherine Filmore and Jenny Young on nutraceutical regulation, which, according to the authors, "is far from clear." Finally, Marc Sanchez provides an analysis of the new FSMA proposed rules on foreign supplier verification and accreditation of third-party auditors that is must-reading for all food law, regulation and policy stakehoders. Hope you enjoy this issue and see you at the Enforcement Conference and Holiday Reception. Michael Levin-Epstein Editor-in-Chief FDLI November/December 2013 Update 7

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013