Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals: A Regulatory Perspective (CE7-1)

The new FDA immunotoxicity guidance is intended to supplement ICH S8, “Immunotoxicity Studies for Human Pharmaceuticals”, and replace the 2002 CDER guidance, “Immunotoxicology Evaluation of Investigational New Drugs”.  Several advancements within the field of immunotoxicology are addressed, including new considerations for the evaluation of immunostimulation, dermal sensitization, and developmental immunotoxicity.  This presentation will provide a detailed overview of this guidance.