Update Nov Dec 2013 - (Page 3)

PREPAREDNES Enforcement FDLI Published by the Food and Drug Law Institute contents The Bioterrorism Act after 5 Years - Is it Working? BioShield II - A StepIssue 6 ■Right Direction? 2013 in the November/December Pandemic Influenza: Companies Should Plan for the Worst and Assess Legal Expo Attack on Multiple Fronts in Nutraceutical Marketing: The Liability Protection: Shielding Vaccine Makers from Litigation FDLI News threat of FTC, FDA and Consumer Class Actions Pet Food Recall - 8 A Look Back at Advertising and PromotionSafety Defenses Exposing Holes in U.S. Food 2013: Highlights from by Kim M. Schmid, Jenny Young, Katherine Fillmore.............. Self-Enforcement of Regulatory Compliance through a Culture of Credibility by Joshua Axelrod, Esq., M.B.A. ............................................. 12 The Impact of Importing Food and Dietary Supplements under the Proposed Foreign Supplier Verification Rule By Marc Sanchez ..................................................................... 16 What FDA's Final Guidance on Mobile Medical Apps Means for Industry By Daniela Pirvu ...................................................................... 20 the "Policy Updates and Enforcement Developments from FDA's Medical Product Centers" Panel By Rachael A. Vieder, Manager, Medical Devices/Drugs Portfolio; Editor ....................................................................... 34 A Look Back at Advertising and Promotion 2013: Trends and Priorities in Enforcement By Jennifer Kane, Manager, Tobacco/Drugs Portfolio; Editor........................................................................................ 36 A Look Back at Advertising and Promotion 2013: Highlights from the Question and Answer Session with FDA Medical Product Center Representatives By Rachael A. Vieder, Manager, Medical Devices/Drugs Portfolio; Editor ....................................................................... 40 A Look Back at Advertising and Promotion 2013: A Call for Clarity in First Amendment Jurisprudence-Top A&P Cases of 2012 and 2013 By Jennifer Kane. Manager, Tobacco/Drugs Portfolio; Editor........................................................................................ 42 Letters The Blumberg Memorial Lecture by Susan C. Winckler, President and CEO ..................................................................... 6 Letter from the Editor by Michael Levin-Epstein, Editor-in-Chief ..................................................................... 7 Columns FDA Issues Final Rule Defining the Term "Gluten Free": What Food Manufacturers Need to Know for Product Labeling By Rebecca Rodriguez, M.S., J.D. ........................................... 24 A Long-Awaited Update to the FDA Draft Medical Food Guidance By Barbara A. Binzak Blumenfeld, Ph.D., J.D. ...................... 26 Thalidomide: The Impact of One Drug on Canadian Drug Regulation By Jill Daley and Kristin Wall .................................................. 30 FDLI November/December 2013 Update 3

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

Update Nov Dec 2013