Ethan Chen

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including Data Management and Business Intelligence programs. While leading the CDER Division of Data Management Service and Solution, Ethan had successfully implemented the eCTD electronic submission mandate in 2017 for NDAs, BLAs and ANDAs, and again in 2018 for Commercial INDs and DMFs (excluding DMF Type III). Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.