Alan G. Minsk

Partner at Arnall Golden Gregory LLP

Speaker

Alan is a partner and co-chair of the Food & Drug practice and 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 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, and food (including dietary supplements and medical foods) companies on all legal and regulatory matters relating to the U.S. 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
• pre-approval discussions

For companies in the commercial phase, Alan advises on:

• promotion and advertising
• interactions with the FDA
• lifecycle management (e.g., next-generation products)
• post-market surveillance
• Citizen Petition submissions
• FDA enforcement and inspections
• fraud and abuse compliance

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.

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. He serves on a number of other professional boards and currently serves as the past president of the Atlanta Jewish Academy.