Dr. John Farley is presently Director of the Office of Infectious Diseases in the Office of New Drugs at CDER, FDA. His office is responsible for the review of new antiviral and antibacterial drugs. In addition to new drug review work, Dr. Farley’s work at FDA has included implementation of the breakpoints provisions of the Cures Act, providing scientific leadership for establishment of the antimicrobial resistance focused regulatory science research program, and serving as a workstream lead for the Integrated Review as part of the Office of New Drugs Modernization. Prior to joining the FDA, Dr. Farley was on the faculty of the University of Maryland School of Medicine and focused care and research on perinatal HIV.