Karen K. Takahashi U.S. FDA

Karen Takahashi is a Policy Lead at FDA in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality. In this capacity, she develops policy on various CGMP-related topics. Earlier in her career, she worked as a Compliance Officer in CDER’s Office of Manufacturing and Product Quality and as an Investigator in New England District Office. Karen holds a Master of Science degree from Boston University and a Bachelor of Science degree from the University of Wisconsin-Madison.