Alan G. Minsk

Partner
171 17th Street NW
Suite 2100
Atlanta, Georgia 30363
404.873.8690 phone
404.873.8691fax

Alan G. Minsk is a partner and leader of the Food and Drug Practice Team. Mr. Minsk is licensed to practice in Georgia and Washington, DC. He works out of AGG’s Atlanta and Washington offices.

Mr. Minsk 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 - 2017. Nominees are selected based upon comprehensive, independent survey work with both General Counsel and private practice lawyers worldwide. He serves as general counsel of PDMA Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability.

Mr. Minsk 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 U.S. Food and Drug Administration. For companies in the pre-approval phase, Mr. Minsk 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 submissions
  • premarket approval applications
  • pre-approval discussions

For companies in the commercial phase, Mr. Minsk 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, Mr. Minsk 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. Mr. Minsk conducts in-house training on FDA and fraud and abuse topics.

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

Mr. Minsk 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 co-editor of AGG's Food and Drug Newsletter. He has spoken throughout the U.S. and in Canada, England, Belgium, Israel, Luxembourg, Germany, and the Netherlands.

He currently serves on a number of editorial boards for professional publications, including the RAPS Focus magazine, the Law Journal Newsletter's Product Liability Law and Strategy, 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 Vice President of the Atlanta Jewish Academy.