Suzan Onel

Background

About Suzan Onel

FDA legal and regulatory counseling. With over 26 years experience, I advise FDA-regulated companies on market entry strategies, labeling and promotional activities, regulatory compliance, recalls and field corrections, and enforcement defense. My practice includes counseling domestic and international companies, trade associations, and clinical research organizations on matters spanning medical devices, foods, dietary supplements, OTC drugs, and cosmetics and private equity/venture capital investors on transactional and due diligence matters involving life science companies. I am co-editor and a contributing author of a book published by PLI on medical devices entitled,"Medical Devices Law and Regulation Answer Book"(in the 5th edition) and a frequent speaker and author on FDA topics including medical device software, functional food, and dietary supplement issues. Specialties: Medical device, food (including functional food and medical food), dietary supplement, drug, and cosmetic law; advertising and labeling; FDA due diligence; manufacturing and distributor agreements. Regular interaction with the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the US Department of Agriculture (USDA), and the National Advertising Division of the Better Business Bureaus (NAD). For more information, click on my professional bio: