Biological Product Regulation

Learn how FDA reviews biologic products throughout the development and review phases of investigational new drug (IND) clinical trials and biologic license application (BLA) submissions. This course covers the evolution of biological product development from vaccines to cellular therapy and their regulation. Learn to identify the characteristics of biologic products as well as the unique aspects of their manufacturing. Participants will also spend time on biologic drug and biologic medical device combination products. Special attention will be given to novel areas of biological product development, namely nanotechnology, cellular therapy, and vaccine delivery systems.