Kalavati Suvarna, PhD Food and Drug Administration

Dr. Kalavati Suvarna is a Senior Clinical Microbiology Reviewer in the Office of Antimicrobial Products within the FDA/CDER’s Office of New Drugs. Kalavati Suvarna received a B.S. in Microbiology in 1985 and M.S. in BioPhysics in 1989 from the University of Bombay, and a Ph.D. in Biological Sciences from Northern Illinois University in 1994. She has extensive experience in both academic and pharmaceutical settings. She joined the FDA in 2001 as a microbiologist and reviewed clinical microbiology aspects of antimicrobial products. She then joined CDER’s Office of Compliance, Office of Manufacturing and Product Quality, Biotech Manufacturing Assessment Branch in 2008 as a Consumer Safety Officer (Senior Policy Advisor). In this position, she reviewed the quality microbiology aspects of biotech products and conducted pre-license and pre-approval inspections of biotech manufacturing facilities. She is involved in training, policy, guidance, and standards setting activities associated with biotechnology, antimicrobial products, and clinical trials. She has won numerous internal awards from FDA/CDER. She is the author of several scientific journal articles and book chapters.