RGA 6600 — Introduction to Food and Drug Administration Pharmaceutical Regulation
3 semester hoursGraduateLecture
Presents an overview of current U.S. biopharmaceutical statutes and regulations. Offers students an opportunity to develop a strong understanding of biopharmaceutical regulatory affairs. Topics include the historical development of U.S. biopharmaceutical regulation, as well as an overview of biopharmaceutical product and clinical development, and applicable U.S. Food and Drug Administration approval processes. Also discusses the potential postmarket approval regulations for biopharmaceutical processes.