Hong Cai PhD U.S. FDA

Dr. Hong Cai is a division director in the Office of New Drug Products within the Office of Pharmaceutical Quality at FDA. Her division performs new drug product quality assessments supporting applications in disease areas including Immunology and Inflammation, Rare Diseases, Urologic, Reproductive and Neuroscience. During her tenure at FDA, Dr. Cai has served as a quality reviewer, a CMC Lead, and a Branch Chief before assuming her current role. Additionally, she serves as the FDA liaison to the USP Expert Committees on Simple Excipients and Complex Excipients (2020-2025). Prior to joining FDA in 2015, Dr. Cai spent more than 17 years in the pharmaceutical industry. Her working experience expands from early drug discovery to late stage development at Johnson and Johnson, Bristol Meyer Squibb, and Glaxo Smith Kline.