Senior Biologist
US Food and Drug Administration
Zhouxi Wang joined CDER FDA in 2017. She has been engaged in conducting quality assessments for a wide range of applications, encompassing original and supplemental ANDAs/NDAs, INDs, PANDAs, facility inspections, and established investigation report reviews. She is an active contributor to in several working groups and initiatives, including Knowledge-aided Assessment and Structured Application (KASA), Pharmaceutical Quality - Chemistry, Manufacturing & Controls (PQ/CMC), guidance drafting, and Deficiency Data Analysis, among others. She earned her Ph.D. in Chemistry from Northeastern University in Boston and holds M. Eng and B. Eng degrees from Donghua University in China.