Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics

On 19 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 20 April 2020.

This guidance expands upon, consolidates, and supplements the recommendations on nonclinical immune system assessments provided across multiple guidance documents, most notably the ICH guidance for industry “S8 Immunotoxicity Studies for Human Pharmaceuticals.” The topics covered include various aspects of immune suppression, modulation, and stimulation. This guidance replaces the withdrawn guidance entitled “Immunotoxicology Evaluation of Investigational New Drugs.”

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