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Kimberly Raines, PhD

Branch Chief, Division of Biopharmaceutics, Office of New Drug Products, OPQ, CDER

Dr. Kimberly Raines is a Supervisory Pharmacologist at the FDA, currently serving as a Branch Chief in the Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality. She received her Ph.D. in pharmaceutical sciences from the University of Maryland School of Pharmacy and a B.S. in chemistry from Duke University.  Prior to joining the FDA, Dr. Raines received post-doctoral training at the University of North Carolina Lineberger Comprehensive Cancer Center. Her tenure at the Agency began in the Office of Generic Drugs as a bioequivalence reviewer and controlled correspondence team lead.  Currently Dr. Raines and ONDP/DB/Branch 3 lead efforts in establishing in vitro dissolution/release specifications for ANDAs and assessing biopharmaceutics topics (e.g., biowaiver, bridging, IVIVC, etc.) for NDAs in the following OND clinical divisions, Cardiology and Nephrology; Diabetes, Lipid Disorders, and Obesity; General Endocrinology; Medical Imaging and Radiation Medicine; Non-Malignant Hematology; Nonprescription Drugs 1 and 2 and Ophthalmology. Additionally, Dr. Raines develops CDER biopharmaceutic guidances, leads research projects within her division, and provides subject matter expertise to FDA policy initiatives. She has co-authored original research articles and presented on bioequivalence, biowaivers, in vitro dissolution, and physiologically based model informed quality risk assessment.

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