Suzan Onel

Suzan Onel

K&L Gates LLP

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FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

3/12/2015 - FDA FDASIA Healthcare Medical Device Accessories Medical Devices Mobile Apps New Guidance Popular

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

10/22/2014 - China Clinical Trials Cosmetics EU Food Labeling Food Manufacturers Food Safety Japan Legislative Agendas Medical Devices Nanomaterials New Legislation Nutrition Facts Labels Pharmaceutical Manufacturers

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

4/9/2014 - Australia China Dietary Supplements EU FDA FDCA Food Labeling Food Safety Generic Drugs Medical Devices Nutritional Supplements Prescription Drugs

Global Food, Drug and Medical Device Newsletter

In this issue: Legislative Updates: - (i) USA - (ii) EU - (iii) China - (iv) Australia - (v) Japan. - Featured Articles: - (i) Caffeinated Energy Drinks - a Global Perspective - (ii)...more

10/10/2013 - Advertising Animal Testing Australia Cosmetics Energy Drinks EU Food Labeling FTC Health Claims Japan Medical Devices Personally Identifiable Information POM Wonderful

Getting Over the Goal Line: Congress Shows Strong Support for Medical Device Tax Repeal, but Issues Remain

Introduction - The Patient Protection and Affordable Care Act (“ACA”) generates very few areas of agreement. However, in recent months, proposals to repeal one of the most visible and controversial provisions of the...more

6/3/2013 - Affordable Care Act Manufacturers Medical Device Tax Medical Devices

FTC Rules that “Randomized Clinical Trial” Evidence is Necessary to Support Advertising Claims for Juice Beverage and Related...

I. Introduction - If you represent food and beverage manufacturers who advertise their products, you will want to be familiar with In the Matter of POM Wonderful LLC, a recent decision by the Federal Trade Commission...more

5/15/2013 - Advertising FTC POM Wonderful

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

12/17/2012 - FDA FDCA First Amendment Marketing Misbranding Off-Label Promotion Off-Label Use Pharmaceutical

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