Alan G. Minsk

Partner

Direct: 404.873.8690
Fax: 404.873.8691
Atlanta
171 17th Street NW
Suite 2100
Atlanta, Georgia 30363

Biography

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.

Credentials

  • Georgetown University Law Center, Juris Doctor
  • Brandeis University, Bachelor of Arts,
    summa cum laude, Highest Honors in Politics
  • District of Columbia 2011
  • State of Georgia 1992
  • United States District Court for the Northern District of Georgia 1997
  • Supreme Court of Georgia 1993
  • Georgia Court of Appeals 1993
    • 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
      • Executive Board
      • Advertising and Promotion for Medical Products Conference Planning Committee, 2024
    • Center for Communication Compliance Advisory Board
  • Hebrew ( Proficient )

Recognition

  • Best Lawyers in America®, Biotechnology and Life Sciences Practice, FDA Law, 2018-24
  • Chambers Global, Life Sciences Regulatory and Compliance – USA, 2020-24
  • Chambers USA: America’s Leading Lawyers, Life Sciences: Regulatory/Compliance, 2015-23
  • JD Supra Readers’ Choice Top Author in Life Sciences, 2018, 2020-21
  • “Global Leader,” Who’s Who Legal, Life Sciences: Regulatory, 2013-23

Food & Drug Podcast

Each month, we will release a new podcast where different members of our Food and Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal issues.