Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals; Guidance for Industry; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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 This guidance finalizes the draft guidance entitled "Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics" issued on February 20, 2020.
Abstract as published in the Federal Register.
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