Diane Romza-Kutz counsels life sciences companies across the globe to proactively address U.S. and E.U. regulatory roadblocks and to navigate the framework of crisscrossing federal, state, and local regulations. She is experienced in representing life science clients from a broad spectrum of industries, including food and food ingredients, dietary supplements, animal health, pharmaceuticals, medical devices, cannabis and agribusiness as well biologics.

Diane partners with her clients to craft sound business strategies that account for the complex interplay among regulators while accounting for risk. She 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 advises clients regarding legal business issues that arise within her clients’ operations, including global licensing agreements, co- development arrangements, good manufacturing compliance, litigation involving pre-emption claims, misbranding, duty to warn, and infringement.

Diane is also experienced in counseling cannabis businesses on how to navigate he tension between the federal government’s regulatory position and states that have legalized marijuana use. She has represented cannabis companies with cannabis operations in several states as well as those companies providing goods and services to cannabis companies. She has also counselled clients on the impact of the Hemp Amendment to the Farm Bill.