We represent clients in regulatory matters relating to food, prescription and non-prescription drugs, biological products, medical devices and cosmetics. Our food and drug law practice includes representation of clients before the Food and Drug Administration and other governmental agencies, as well as litigation and transactional work. We assist clients in obtaining FDA approval of new products and advise clients on regulatory approval strategies, clinical trial development and design, product labeling and manufacturing issues.We have specific experience with laws covering the development and commercialization of pharmaceutical products and medical devices, including the legal and regulatory standards governing the promotion of products in accordance with FDA regulations and the Lanham Act. We also represent clients in government enforcement and compliance matters.
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