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Michael Swit's Page
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- About Me:
- Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP INC., a premier international scientific and regulatory consulting firm headquartered in Washington, D.C., where he develops and ensures the execution of a broad array of regulatory and other services to pharmaceutical, biotech, device and diagnostic clients, both directly and through outside counsel. His expertise includes product development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts. Both his own practice and that of his firm encompasses not only drugs, biologics, and therapeutic biotech products, but extensive experience with device, IVD, and other life sciences companies, as well as those in the food and dietary supplement industries.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His vast and multi-faceted experience includes serving for three and a half years, from 1990 to late 1993, 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. Mr. Swit then served for over four years as CEO of Washington Business Information, Inc. (now known as FDANews), 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. He earned his A.B., magna cum laude, with high honors in history, from Bowdoin College, and his law degree at Emory University School of Law. Mr. Swit is admitted to the D.C., Virginia and California bars.
ABOUT THE WEINBERG GROUP
The Weinberg Group Inc. is a premier regulatory and scientific consulting firm dedicated to helping highly-regulated drug, biologic, biotech, medical device and diagnostic companies develop and execute regulatory, clinical and quality strategies to take products from initial development all the way through regulatory approval/clearances processes both in the United States and in Europe. And, once on the market, our experts apply sound science to help ensure our clients' products stay on the market in the face of attack, whether in products liability litigation, from governmental authorities, or other sources such as adverse published literature.
To access our website, visit www.weinberggroup.com.
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- http://www.weinberggroup.com
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Just wanted to stop in and get your opinion on my latest cover design posted to my blog...
I would love your input.
Aidana WillowRaven
www.WillowRavenIllustration.com
901-325-1402