Business Talk

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing.

What are nonclinical studies and when are they conducted in drug development?

Before a drug or biological product can be moved into clinical studies, sponsors must conduct nonclinical studies to demonstrate the product is reasonably safe and that its pharmacological effects and mechanisms of action are sufficiently characterized.

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