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About Michael A. Swit, Esq.
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
understanding of both the bounds of the law and agency policy...
governing pharmaceuticals, biologics, medical devices and other
FDA-regulated products requires experienced, well-honed insights and
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 recently
returning to private law practice, Mr. Swit served for seven years as a Vice President at The Weinberg Group,
a preeminent scientific and regulatory consulting firm headquartered in Washington, D.C., where he
developed and ensured execution of a broad array of regulatory and other services to clients, both directly and
through outside counsel. His expertise includes FDA development 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 and dietary supplement industries.
Mr. Swit's multi-faceted experience includes serving for three and a half years as corporate vice president,
general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company 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, both in the firm's Washington office and later in San Diego. He first practiced FDA
regulatory law with the D.C. office of Burditt & 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 hockey, basketball and baseball fan (and ex-player), and the father of triplet sons,
born Feb. 29, 1996.
returning to private law practice, Mr. Swit served for seven years as a Vice President at The Weinberg Group,
a preeminent scientific and regulatory consulting firm headquartered in Washington, D.C., where he
developed and ensured execution of a broad array of regulatory and other services to clients, both directly and
through outside counsel. His expertise includes FDA development 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 and dietary supplement industries.
Mr. Swit's multi-faceted experience includes serving for three and a half years as corporate vice president,
general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company 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, both in the firm's Washington office and later in San Diego. He first practiced FDA
regulatory law with the D.C. office of Burditt & 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 hockey, basketball and baseball fan (and ex-player), and the father of triplet sons,
born Feb. 29, 1996.
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