Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals; Guidance for Industry; Availability

الملخص

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals." This guidance finalizes the draft guidance entitled "Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics" issued on February 20, 2020.