FDA guidance on nonclinical evaluation of immunotoxicity
In June 2023 FDA finalized the guidance document, “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.” The purpose of this guidance is to assist sponsors in the nonclinical evaluation of the immunotoxic potential of drug products and biopharmaceuticals.
The guidance addresses evaluation of topical pharmaceuticals for skin sensitization potential. Specifically, the guidance states that, for individual chemicals, “FDA will consider a battery of studies (e.g., in silico, in chemico, in vitro) that have been shown to adequately predict human skin sensitization with an accuracy similar to existing in vivo methods.”