Beth Luoma, J.D., is an associate attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Her practice focuses on counseling clients on compliance in a wide range of relevant laws and regulations, such as the FD&C Act, FDA regulations, Anti-kickback Statute, False Claims Act, and relevant privacy and disclosure laws (HIPAA, Sunshine, etc.). Beth also works extensively in developing compliance policies and delivering training on these topics, as well as assisting clients with FDA marketing submissions and applications (pre-submissions, 510(k)s, de novos, PMAs, etc.), and drafting and negotiating contracts (consulting agreements, NDAs, CTAs, etc.).
Beth brings over decade’s worth of experience in working with industry. Prior to coming on as regulatory counsel at DuVal & Associates, she worked at device and pharmaceutical CROs delivering a wide range of clinical trial services.
Beth earned her Juris Doctor from the University of St. Thomas School of Law, and her Bachelor of Arts in Political Science from the University of Minnesota – Twin Cities.