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Donald E. Segal

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T: 202-239-3449
F: 202-654-4939
Partner
T: 202-239-3449
F: 202-654-4939

Donald Segal practices primarily in food, drug and medical device regulation. Mr. Segal provides counsel to pharmaceutical, medical device, biologic, food and cosmetic companies regulated by the FDA. He has practiced food and drug law, health care law and administrative law for over 25 years in national law firms and at the FDA, where he served as Associate Chief Counsel.

Mr. Segal focuses on providing strategic advice, and legal and regulatory counsel to a variety of product manufacturers, distributors, hospitals and service providers regarding market entry issues and compliance matters involving marketed products. For example, he assists clients in responding to preparing pre-market submissions and the review of labeling and advertising. He advises clients on recalls, adverse events reporting and current good manufacturing practices (GMPs). Mr. Segal has assisted clients with responding to inspectional findings and warning letters, preparing regulatory sections of securities filings, and preparing and negotiating licensing and contractual agreements. He has also represented companies in litigation regarding injunctions, seizures and intellectual property issues.