FDA Advises Sponsors of New Drugs, Biologics on Assessing Immunotoxicity

The FDA details how sponsors of nonclinical safety evaluations of new drugs and therapeutic proteins should consider their impact on the immune system in a draft guidance.

“Safety evaluation of these drugs and biological products should include evaluating both the intended and the unintended actions on the immune system,” the agency says, noting that effects can include “a reduction or an increase in activity, as well as changes in the immune balance.”

The draft includes separate sections on assessing the potential for products to reduce and the potential to increase immune activity.