Business · 11/05/2001Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Evaluating Immunotoxicity of Investigational New Drugs
Summary
The Food and Drug Administration (FDA) has made available a draft guidance document for industry, outlining recommendations for assessing the impact of investigational new drugs on the immune system, and when additional studies are necessary to evaluate potential immunotoxic effects.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →