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Michael A. Swit has been addressing critical FDA legal and regulatory issues since 1984. His vast and
varied experience, which he is now providing as a solo practitioner, includes serving for three and a half
years as corporate vice president, general counsel and secretary of Pharmaceutical Resources, Inc. (PRI) a
prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial
perspective to his representation of FDA-regulated companies.
While at PRI from 1990 to late 1993, Mr. Swit spearheaded the company’s defense of multiple grand jury
investigations, other federal and state proceedings, and securities litigation stemming from the acts of prior
management. Mr. Swit then served from 1994 to 1998 as CEO of Washington Business Information, Inc.
(WBII) a premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA-regulated community. From May 2001 to May 2003, Mr. Swit was Special Counsel in the FDA Law
Practice Group in the San Diego office of Heller Ehrman White & McAuliffe. Before that, he was twice in
private practice with McKenna & Cuneo, from 1988 to 1990 and, most recently, from 1999 to 2001, first in the
firm’s Washington office and then in San Diego. He first practiced FDA regulatory law with the D.C. office
of Burditt & Radzius from 1984 to 1988.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law 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, he also has been a prominent speaker at numerous conferences sponsored by such
organizations as RAPS, FDLI, and DIA.
A member of the California, Virginia and District of Columbia bars, Mr. Swit is also an avid hockey,
basketball and baseball fan (and ex-player), and the father of triplet sons, born Feb. 29, 1996, and is married to
Vera Caccioppoli, an accomplished creative writer, artist, and jewelry designer.
For a copy of Mr. Swit's full CV, click here ....
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