Partner & Leader, Food & Drug Practice Group
Arnall Golden Gregory, LLP
Alan is a partner and leader of the Food & Drug practice. He advises pharmaceutical, biologic, medical device, cosmetic and food companies (including dietary supplements and medical foods) on all legal and regulatory matters relating to the U.S. Food and Drug Administration. He counsels clients on a wide variety of FDA-related issues including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. 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. Alan conducts in-house training on FDA and fraud and abuse topics.
Alan serves as general counsel of Sharing Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act, fraud and abuse compliance, and sample accountability. He 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 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. Alan is nationally recognized by Chambers USA for “Life Sciences: Regulatory/Compliance” has been selected for inclusion in the international publication of Who’s Who Legal for “Life Sciences: Regulatory” and is recognized by Best Lawyers for “FDA Law”.
Tuesday, September 15, 2020
1:00 PM – 2:30 PM EDT