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James S. Cohen Joins McDermott Will & Emery To Lead FDA Practice

WASHINGTON, D.C. - McDermott Will & Emery has announced that James S. Cohen joined the firm's Health Industry Advisory and Life Sciences & Medical Devices Practice Groups as a partner and leader of the firm's FDA practice in the Washington, D.C., office on July 27.

Cohen focuses his practice on the development, clinical investigation, approval, manufacturing, distribution and marketing of pharmaceuticals, biologics, medical devices and combination products. A significant portion of his practice is devoted to counseling and defending clients in compliance investigations and enforcement actions undertaken by the U.S. Food & Drug Administration (FDA), U.S. Department of Justice and other federal and state agencies.

Cohen spent more than 17 years in senior FDA regulatory positions, including as deputy and acting director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, and as associate chief counsel for Enforcement, Drugs, and Biologics. He joins McDermott from the Washington office of a national law firm.

Pharmaceutical, biologic and medical device clients rely on Cohen to advise and represent them in all phases of pre-market review and post-market regulation. Representative matters that he handles include oversight of clinical investigations, product application issues, product jurisdiction issues, response and defense to FDA inspection, compliance and enforcement actions, defense to Department of Justice investigations, advertising and promotion, recalls, citizen petitions, and CMS coverage and rebate issues. As a leader of the FDA Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, he directed and managed the agency's activities in these areas for biological products (including biological drugs and devices) and oversaw a variety of compliance issues.

In addition, Cohen served for eight years as associate chief counsel in the Office of the Chief Counsel at the FDA, where as an enforcement attorney he conducted civil and criminal enforcement litigation in all major product areas regulated by the FDA. During this time, he also served as a special assistant U.S. attorney in three federal jurisdictions. He received numerous awards at the FDA, including the Award of Merit and Distinguished Service Award, and served in the federal government's Senior Executive Service.

Cohen has spoken on FDA regulation at numerous conferences and programs, domestically and internationally, to product manufacturers, industry organizations and government officials. He is admitted to practice in the District of Columbia, in Massachusetts and before a number of federal courts, including the U.S. Supreme Court. Cohen received his J.D. degree from Georgetown University Law Center, Washington, D.C., in 1983.

McDermott's Life Sciences & Medical Devices Practice Group provides fully integrated, multidisciplinary legal services to life sciences companies, regardless of their stage of development. Life Sciences is a major focus of McDermott and in recent years has enhanced its resources with the addition of leading pharmaceutical, biotechnology and medical device practitioners.

McDermott Will & Emery is a leading international law firm with more than 1,000 lawyers in Boston, Brussels, Chicago, Düsseldorf, Houston, London, Los Angeles, Miami, Milan, Munich, New York, Orange County, Rome, San Diego, Silicon Valley and Washington, D.C., as well as a strategic alliance with MWE China Law Offices in Shanghai. For more information, see