| 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 all areas of FDA regulation and related laws, including the Anti-kickback Statute, False Claims Act and HIPAA Privacy Regulations. Beth’s regulatory practice focuses on researching and providing regulatory opinions, and working with clients on domestic and foreign premarket submissions. She also drafts and negotiates agreements on behalf of her clients for US/international clinical trials and consulting arrangements. Prior to her legal career, Beth worked for various medical device and pharmaceutical CROs supporting clinical trials. In total, Beth has served the industry through various roles for nearly a decade. 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. |