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Business · 20/02/2020Updated: 10/17/2026 · 1 min read

FDA Announces Draft Guidance on Immunotoxic Potential of Drugs and Biologics

Summary

The FDA has released a draft guidance document outlining the nonclinical safety evaluation of immunotoxic potential for drugs and biologics, replacing a withdrawn guidance and consolidating recommendations from multiple ICH guidance documents.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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