Duane Morris is pleased to announce that Michael A. Swit has joined the firm’s Trial Practice Group as special counsel in its San Diego office. Swit’s arrival further bolsters Duane Morris’ life sciences practice, particularly in U.S. Food and Drug Administration (FDA) regulatory matters. Prior to joining Duane Morris, he served for seven years as vice president of The Weinberg Group, Inc.—a scientific and regulatory consulting firm.

Swit focuses his practice on counseling life sciences firms in complying with the FDA’s statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. His work includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions, labeling and advertising, and clinical research efforts. He has also advised regulated firms on drug and device approvals, dietary supplement health claims and corporate acquisitions.

Swit brings more than a decade of in-house leadership experience at companies with substantial business interests in the activities of the FDA. While at The Weinberg Group, he developed and ensured execution of a broad array of regulatory and other services to clients. Earlier in his career, he served for more than three years as corporate vice president, general counsel and secretary of Par Pharmaceutical Inc., a prominent and publicly traded generic drug company. Swit then served for more than four years as CEO of FDAnews.com, a publisher of FDA regulatory newsletters and other specialty information products.

Swit has taught and written on numerous subjects relating to the FDA and related commercial activities. Since 1989, he has co-directed a three-day intensive course on the generic drug approval process, and edited a guide titled “Getting Your Generic Drug Approved.” A former member of the Food and Drug Law Journal editorial board, Swit also has spoken at numerous conferences sponsored by the Food and Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS) and the Drug Information Association (DIA).

Swit earned his J.D. in 1982 from Emory University School of Law and earned his A.B., magna cum laude, with high honors in History from Bowdoin College in 1979.

Duane Morris’ Life Sciences and Biotechnology practice offers clients a full range of legal services—including intellectual property counsel, securities counsel in connection with private and public equity funding, international trade and tax advice, labor and employment guidance, dispute resolution and litigation services.

In addition, attorneys in Duane Morris’ ANDA and Generic Pharmaceuticals practice focus on the representation of worldwide generic pharmaceutical companies in their quest to enter the U.S. market with new products. They have significant experience in representing clients in litigation related to abbreviated new drug applications filed under the Hatch-Waxman law, as well as generation of non-infringement, invalidity and freedom-to-operate opinions with respect to patents listed in the Orange Book. Mr. Swit’s involvement with Hatch-Waxman issues, dating to 1984, will further augment this practice.

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