Comparison of two guidelines on immunotoxicity testing of medicinal products.

Despite the lack of formal immunotoxicity testing guidelines, the assessment of immune function has been a routine component of toxicity testing for over twenty years. The European Agency for the Evaluation of Medicinal Products (EMEA) and The US Food and Drug Administration (FDA) have recently adopted new guidelines for immunotoxicity testing of new medicinal products. These two guidelines are compared in this article.