The last several years have witnessed many advancements within the field of immunotoxicology. These advancements include new therapeutic options to treat inflammatory and autoimmune diseases, identification of new immune targets, mechanisms, and potential safety concerns, and the development of new immunotoxicity assays. The types of immune effects encountered can vary dramatically and present unique challenges during drug development. This session will address the various types of immunotoxicities, and the nonclinical assays and strategies used to address them. An overview of the guidance documents pertinent to nonclinical immunotoxicity assessment will also be included.