Researcher/reviewer
I became a subject matter expert over the course of three decades of genotoxicity data review experience with mainly medical device and drug submissions, but also occasionally for veterinary and food contact products or food and cosmetic dyes. We were accustomed to working in teams, which I learned to value in relation to integrating diverse sets of expertise, mine being determination of genotoxicity. The FDA Center for Medical Devices and Radiological Health (CDRH) with engineers, physicists, chemists and software engineers is the most diverse FDA center. It was satisfying to provide a useful contribution to product safety assessment. Eventually I ran or participated in genotoxicity training sessions in specific centers or FDA-wide over many decades. Assessment of cancer risk (via surrogate genotoxicity) was a legal requirement for most FDA-regulated products (except biologicals).