ALAN G. MINSK is a partner and leader of the Food and Drug Practice Team at Arnall Golden Gregory LLP. Alan is licensed to practice in Georgia and Washington, D.C. He works out of AGG’s Atlanta and Washington offices. Alan is recognized by Chambers USA America’s Leading Lawyers for Life Sciences, Regulatory/Compliance and has been selected for inclusion in the International Who’s Who of Life Sciences Lawyers from 2013 – 2021. He serves as general counsel of The Sharing Alliance Inc. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, and food (including dietary supplements and medical foods) companies on all legal and regulatory matters relating to the US Food and Drug Administration. He counsels on the following areas: clinical trial issues, communications with the FDA during the review process, imports and exports, regulatory strategy including 505(b)(2) new drug applications, orphan drug designation, Fast Track and Breakthrough Therapy designations, combination product determinations, market exclusivity, premarket notification (510(k)) submissions, premarket approval applications, and pre-approval discussions. In addition, Alan works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, regulatory opinion letters, co-promotions, and licensing agreements. He also drafts and reviews agreements relating to clinical trials, quality, and contract manufacturing. He conducts in-house training on FDA and fraud and abuse topics. He currently serves on a number of editorial boards for professional publications, including the Food and Law Drug Institute’s Food and Drug Law Journal.