Suzan Onel

Suzan Onel

K&L Gates LLP

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U.S. FDA Finalizes Medical Foods Guidance

On May 12, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its 2013 draft guidance for industry, “Frequently Asked Questions About Medical Foods; Second Edition.” Despite significant industry...more

6/2/2016 - FDA FDCA Final Guidance Food Labeling Medical Foods

Vermont Act 120 and Beyond: Genetically Engineered Foods, Where Are We Now?

On July 1, 2016, Vermont’s genetically engineered food labeling law is set to become effective. Act 120 and its implementing rule (Vermont Consumer Protection Rule 121) require food manufacturers to label food products that...more

5/13/2016 - Exemptions FDA FDCA Food Labeling Food Manufacturers GMO New Legislation Preemption Proposed Legislation

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

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 Industry

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