Bita Mirzai-Azarm, MS FDA

Bita Mirzai-Azarm is a Branch Chief in the U.S. FDA’s CDER/ Office of Pharmaceutical Quality/ Office of Lifecycle Drug Products/ Division of Liquid Drug Products.  Her Branch specializes in drug product quality reviews of generic injectable drug products (injection solution/suspension/emulsion; sterile powder for injections; injection combination products such as prefilled syringes, auto-injectors, IV bags).  In her role as Branch Chief, Bita provides technical and managerial leadership to her review team.  During her 20 years of federal service, Bita has been involved in CDER in various capacities. She has served as acting Deputy Division Director in the Office of Pharmaceutical Sciences, as Lead Chemist and Senior Review Chemist in the Office of Generic Drugs. Prior to joining the federal government, Bita worked as an associate scientist for 3 years at Schering-Plough Research Institute.  Bita graduated with B.Sc. (honors) AND M.Sc. from University of Manitoba, Canada.