51ÊÓƵ

This course examines how "drugs", "biologics" and "cellular therapies" are evaluated, manufactured and sold in the United States. cGMP's, clinical trials, INDA, NDA, ANDA, PLA, ELA, validation, Q.A., Q.C., interactions with FDA staff and with company product and process development, regulatory affairs, drug metabolism, medical affairs, and production are covered in a lecture and project format.