Stories From The Lab

I work as an Epidemiologist as part of FDA’s Center for Drug Evaluation and Research safety team. We work to ensure that FDA-approved medications are safe for the public. In addition to assessing newly published literature on FDA-regulated products and giving input on sponsor submissions, together with the team, I take a lead in conducting safety assessments of drugs covered by my team using FDA's Sentinel Initiative. Sentinel is an active surveillance monitoring system for medical products that uses linked administrative and insurance claims databases. Sentinel helps us to investigate safety questions about the products FDA regulates after they are on the market.

It’s exciting to be on the frontlines of exploring this powerful tool and helping to identify safety issues of interest to FDA and critical to the public. It’s really interesting to get the results from our queries and to help interpret the data we get back.