Kassa Ayalew, M.D., M.P.H.

Branch Chief, Good Clinical Practice Assessment Branch Division of Clinical Compliance Evaluation, Office of Scientific Investigation Center for Drug Evaluation and Research U.S. Food and Drug Administration

Dr. Ayalew is a branch chief for the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). He oversees verification of the integrity of efficacy and safety data submitted to the FDA in support of new drug and biologic applications and the protection and assurance of the rights and welfare of human research subjects.

Dr. Ayalew obtained his M.D. from Haile Selassie University Medical Faculty in Addis Ababa, Ethiopia. He then worked as an assistant professor in the Department of Pediatrics at the Gondar University of Medical Sciences in Ethiopia and completed post-graduate training in pediatrics and child health at Leipzig University in Germany. He also completed a pediatrics residency at the Long Island College of Medicine followed by a fellowship program at Children’s National Medical Center/George Washington University.

Dr. Ayalew is a Pediatrics Infectious Disease physician and holds an active license to practice medicine in Virginia. He serves as a pediatrician at Inova Fair Oaks Hospital where he provides clinical services in pediatrics and pediatric infectious diseases. He has given numerous didactic lectures and case presentations and has published article in peer review journals. He holds several awards and credentials from the FDA, where he has 18 years of regulatory medicine and work experience.