Karen Takahashi

Senior Policy Advisor, Office of Policy for Pharmaceutical Quality, CDER

---

Karen Takahashi is a Senior Policy Advisor in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality. Prior to January 2015, she spent fifteen years as a Senior Policy Advisor and Compliance Officer in CDER’s Office of Manufacturing and Product Quality. At the beginning of her FDA career, Karen was an Investigator with FDA’s New England District Office. She holds a Master of Science degree from Boston University, and a Bachelor of Science degree from the University of Wisconsin-Madison.