Kai Kwok FDA CDER
Kai Kwok FDA CDER Senior Pharmaceutical Quality Assessor
Dr. Kwok is a Senior Pharmaceutical Quality Assessor (SPQA) in the Division of Product Quality Assessment I (DPQA I), Office of Product Quality Assessment I (OPQA I), Office of Pharmaceutical Quality (OPQ), CDER at FDA. In this role, he acts as the application technical lead for integrated quality assessment of generic parenteral, ophthalmic, topical, nasal, and oral solid/solution drug products. For the past 10 years, he has been reviewing ANDA, Bio-IND, and Pre-ANDA meeting packages involving complex drug products. Also, he served as a FDA liaison in the USP Packaging and Distribution Expert Committee for developing USP packaging chapters and standards and as a member for development of FDA guidance for drug delivery performance of drug-device combination products. Prior to FDA, he spent over 10 years as a formulation scientist for drug product and process development in pharmaceutical companies. He received his BS in Pharmacy from Temple University and PhD in Pharmaceutical Sciences from University of Michigan.