Navigating successfully the maze of legal and regulatory requirements governing pharmaceuticals, biologics, medical devices and other FDA-regulated products requires experienced, well-honed insights and a deep understanding of both the bounds of the law and agency policy...
Michael Swit has been addressing critical FDA legal and regulatory issues since 1984. Before returning to private practice in late 2017, Swit served as the chief regulatory and quality lawyer at Illumina, the leading developer of gene sequencing technology. Prior to joining Illumina in December 2014, he was at Duane Morris LLP as a Special Counsel in the firm's FDA Law Group in its San Diego office from March 2012. Before Duane Morris, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA regulatory consulting firm headquartered in Washington, D.C., where he developed and ensured execution of a broad array of regulatory and other strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food, cosmetic, and dietary supplement industries.
Mr. Swit's multi-faceted experience includes serving for three and a half years as corporate vice president and general counsel of Par Pharmaceutical, a major publicly-traded generic drug manufacturer and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. While at Par, he spearheaded Par's successful response to multiple federal and state criminal and civil investigations arising out of the actions of prior management. Mr. Swit then served for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community.
His private FDA regulatory law practice has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo (now Denton's), both in the firm's Washington office and later in San Diego. He also has been a solo FDA law practitioner. He first practiced FDA regulatory law with the D.C. office of Burditt Bowles & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA.
A magna cum laude graduate of Bowdoin College, with high honors in history, Mr. Swit received his law degree from Emory University School of Law. He is a member of the California Bar and was admitted previously in both Virginia and the District of Columbia, but is not currently active in either jurisdiction.
Mr. Swit is also an avid cyclist and hockey, basketball, and baseball fan, and the father of triplet sons, born on Leap Day, February 29, 1996.
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