USA – FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance

The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and withdrew an earlier 2002 guidance on the topic.

FDA says the guidance addresses issues related to evaluating immunotoxicity including immune suppression, modulation and stimulation and provides recommendations for carcinogenicity assessments, dermal sensitization, adjuvanted vaccine development and developmental and juvenile animal studies.

The 10-page draft guidance consolidates and supplements recommendations from various guidances, including the International Council for Harmonisation (ICH) S8 Immunotoxicity Studies for Human Pharmaceuticals guideline and FDA’s 2006 guidance Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications