Mr. Tjoe is a member of the Food and Drug Law Institute (FDLI), and a member of the FDLI New to Food and Drug Law Group Planning Committee.
Prior to joining Goodwin, Mr. Tjoe served as a regulatory counsel in the FDA’s Center for Devices and Radiological Health (CDRH). At FDA, Mr. Tjoe advised premarket review teams and senior management on regulatory issues arising from premarket review and classification, provided counsel and strategic advice on agency enforcement actions, and advised agency officials on issues related to the development and implementation of agency regulatory policies and regulations and the application of legislation impacting FDA regulation. He was responsible for providing counsel on a variety of regulatory matters across multiple sectors, particularly in the evolving fields of precision medicine and digital health. In recent years, Mr. Tjoe was lead regulatory counsel for FDA’s Office of In Vitro Diagnostics and Radiological Health (now Office of Health Technology 7) on numerous issues pertaining to the regulation of genetic testing, companion diagnostics, and laboratory developed tests.
