Mai X. Huynh, MS U.S. FDA

Mai Huynh is the Team Leader of the Sterile Drugs Team in the Division of Manufacturing Technologies/FDA/ Center for Veterinary Medicine. The Sterile Drugs Team is responsible for the review of pre and post-approval pioneer applications for veterinary injectable drug products. Mai joined CVM in 1989 as a manufacturing reviewer, became a team leader and also a master reviewer for her expertise in sterility assurance validation and modified release injectables. Mai is an active member of the Parenteral Drug Association and serve as government liaisons for several USP Expert Committees. Mai is CVM’s VICH Quality Lead, as well as a member of several FDA's inter-center manufacturing working groups.