DIANE ROMZA-KUTZ



Diane Romza-Kutz helps life sciences companies develop new products and bring them to market amid a scatter of regulatory land mines that can delay or destroy the path to profits. Diane works with companies in the businesses of food, dietary supplements, animal health, prescription/over-the-counter drugs, biologics, medical devices, tobacco and agribusiness – clients that all face a similar framework of crisscrossing federal, state and local regulations.

Diane partners with her clients to craft sound business strategies that account for the interplay among all regulators, and her discerning knowledge of these regulatory agencies gives her clients an edge in gaining and maintaining marketplace dominance. Diane closely monitors and counsels clients throughout a product's lifecycle on matters pertaining to the:

      • U.S. Food and Drug Administration
      • U.S. Department of Agriculture
      • Federal Trade Commission
      • Drug Enforcement Administration

Diane also handles intellectual property matters and tackles many other legal business issues that arise within her clients' operations. Notably, she negotiates global licensing agreements and directs litigation involving pre-emption claims, misbranding, duty to warn, and licensing and infringement.

Although Diane serves a multifaceted group of clients, she holds special affinity for animal health. She is a self-described animal lover and a proud horse owner. Recently, she witnessed first-hand how life sciences technology has the power to transform lives when one of her own horses was given an extended life through a surgical procedure and the use of stem cells. To that end, Diane is proud to have served as regulatory counsel in the IPOs of two animal health companies.

Before entering private practice, Diane was supervising attorney for the Chicago Board of Education and also served as an assistant state's attorney for the Criminal Prosecution Division, where she supervised the Child Sexual Exploitation Unit. In addition, she taught criminal justice and domestic violence courses, as well as guest-lectured on FDA matters at Loyola University.

Diane is an established speaker and author on a variety of life sciences topics, including pharmaceuticals, biotechnology, clinical trials, pediatric drug testing, and drug advertising. She also lectures and writes on the subjects of risk management and litigation issues affecting life science companies, food companies and research hospitals and routinely addresses life sciences conferences in the United States and overseas.