Origins and Overview of Drug Law Regulation: An Introduction
A session from FDLI’s Introduction to Drug Law and Regulation
Recorded April 22-23, 2025
Origins and Overview of Drug Law Regulation: An Introduction
Learn the current regulatory framework and major statutory underpinnings for drug regulation. Recognize the sources of legal and regulatory requirements and FDA policies. Understand participation in FDA policy making.
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2025.
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 ALAN G. MINSK is a partner, chair of the Food & Drug practice, and co-chair of the Life Sciences industry team. Alan is licensed to practice in Georgia and Washington, DC. He works out of Arnall Golden Gregory’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 2013–2024. 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 FDA. 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 G. MINSK is a partner, chair of the Food & Drug practice, and co-chair of the Life Sciences industry team. Alan is licensed to practice in Georgia and Washington, DC. He works out of Arnall Golden Gregory’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 2013–2024. 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 FDA. 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.

























































































































