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, DC. 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 – 2020. Nominees are selected based upon comprehensive, independent survey work with both General Counsel and private practice lawyers worldwide. He serves as general counsel of The Sharing Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the US Food and Drug Administration. For companies in the pre-approval phase, 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. Alan’s client base is primarily focused on early-stage to mid-sized life science companies, where he must clearly articulate the legal and regulatory issues for consideration while also recognizing the client’s business realities and needs. He currently serves on a number of editorial boards for professional publications, including the RAPS Focus magazine and the Food and Law Drug Institute’s Food and Drug Law Journal.