Randa F. Melhem, PhD U.S. FDA

Dr. Melhem is a Senior Chemistry, Manufacturing and Controls (CMC) Reviewer in the Division of Manufacturing and Product Quality, Office of Compliance and Biologics Quality at CBER/FDA. In this position Dr. Melhem performs CMC/Facility reviews of Biologics License Applications (BLA) and supplements, and she conducts pre-license and pre-approval inspections of manufacturing facilities for cell therapy products, viral vaccines, plasma derivatives and recombinant products, combination products, and in-vitro diagnostic products regulated by CBER. Additionally, Dr. Melhem reviews Investigative New Drugs (IND), Medical Devices, New Drug Applications (NDA) and supplements for CBER regulated products. Before joining FDA, Dr. Melhem worked in the Biotech industry and in Academia. Dr. Melhem received her PhD from Purdue University, and did her postdoctoral training at the University of Pittsburg, University of Michigan Medical School, and Georgetown University Lombardi Cancer Center.