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).