Thompson Coburn

Diane Romza-Kutz

Partner, Thompson Coburn

Diane helps life sciences companies develop new products and bring them to market while proactively addressing the regulatory land mines that can delay or destroy the path to profits.

She works with life science companies in the businesses of food and food ingredients, dietary supplements, animal health, prescription/over-the-counter drugs, medical devices, tobacco and agribusiness, and biologics — 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 complex interplay among regulators. 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 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. 

As a member of Thompson Coburn's cannabis practice, Diane counsels cannabis businesses on how to navigate the tension between the federal government's regulatory position and states that have legalized marijuana use. 

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