Alan G. Minsk

Practice Areas

Alan is a partner and leader of the Food & Drug practice team and co-chair of the Life Sciences industry team. Alan is licensed to practice in Georgia and Washington, D.C. He works out of AGG’s Atlanta and Washington offices.

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 U.S. Food and Drug Administration. He also 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.

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-size 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. Clients frequently refer to him as “practical,” “responsive,” and “cost-effective,” and he tries to educate as well, eschewing legalese, so clients understand the issues and parameters of solutions. Alan also provides in-house training for clients and speaks at educational conferences.

Professional Memberships

MedTech, Devices and Digital Health Council at Conexx: The America-Israel Commercial Alliance, Chair

University of Georgia Regulatory Affairs Graduate Educational Program Advisory Board

Food and Drug Law Journal, Editorial Board

Atlanta Jewish Academy, Board of Trustees, Past President

Georgia Biomedical Partnership

Food and Drug Law Institute

Center for Communication Compliance Advisory Board

Publications

Alan has written book chapters, articles, and bulletins on a wide variety of issues, including 505(b)(2) NDAs, orphan drugs, product promotion, quality agreements, compliance, and medical device regulation. He is the editor of AGG’s Food and Drug Newsletter. He has spoken throughout the U.S. and in Canada, Israel, and Europe. Alan 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 Journal.