Jacqueline Chan is an associate whose practice focuses on advising and representing large, small, and start-up companies regulated by the Food and Drug Administration regarding regulatory compliance and potential liability issues. She regularly counsels domestic and foreign medical device, food/food additive, cosmetic, dietary supplement, pharmaceutical, tobacco, and consumer product clients on a broad range of matters including labeling and promotional activities, enforcement risk assessment and defense, FDA submissions, post-marketing obligations, state regulatory compliance, and regulatory strategy development. Ms. Chan’s practice also includes FDA due diligence investigations for transactional matters involving FDA-regulated company acquisition and divestment.

Ms. Chan currently serves on the Editorial Advisory Board of the Food and Drug Law Institute’s (FDLI) Update magazine. She speaks and writes on various food and drug law topics, including regulatory issues related to food labeling, novel medical device technologies including 3D printing, medical apps, and software, and medical device premarket submission pathways. She also previously served as a co-author of the American Bar Association’s Food, Cosmetics, and Nutraceuticals Committee’s FCN Digest, discussing key developments in the food, cosmetics, and nutraceuticals industry.

Prior to joining the firm, Ms. Chan worked as an FDA associate at a global law firm and as a litigation associate at a D.C.-based law firm. As a litigation associate, she primarily represented FDA-regulated manufacturers in complex products liability litigations in state and federal courts across the country, including multidistrict litigations and consolidated mass tort proceedings. She also served as a law clerk for the Hon. Patrick L. Woodward of the Maryland Court of Special Appeals. Ms. Chan earned her B.A. in International Relations from the Johns Hopkins University (with honors) and her J.D. from the George Washington University Law School.

Ms. Chan’s publications include the following representative sampling:

  • Chapters: “Devices with Unique Issues – Combination Devices, Radiological Devices, Restricted Devices, Custom Devices, and Device Software” and “Continuing Medical Education (CME) and Industry-Supported Scientific Activities,” PLI Medical Devices Law and Regulation Answer Book 2017;
  • Chapter: “Sandoz Inc. v. Amgen Inc.,” Food and Drug Law Institute Top 20 Food and Drug Cases, 2014 and Cases to Watch, 2015;
  • Chapter: “Mutual Pharmaceutical Company v. Bartlett,” Food and Drug Law Institute Top 20 Food and Drug Cases, 2013 and Cases to Watch, 2014 (Co-Author); and
  • Chapter: “Continuing Medical Education (CME) and Industry-Supported Scientific Activities,” PLI Medical Devices Law and Regulation Answer Book 2015 (September 2014, Co-Author).

Ms. Chan’s recent speaking engagements include the following:

  • Panelist, “FDA’s 510(k) Premarket Notification Program,” The Center for Professional Advancement
  • Presenter, “Overview of Medical Device Law and Regulation,” Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation Program