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FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance

Posted 19 February 2020 | By Michael Mezher 

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The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and withdrew an earlier 2002 guidance on the topic.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The 10-page draft guidance consolidates and supplements recommendations from various guidances, including the International Council for Harmonisation (ICH) S8 Immunotoxicity Studies for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.
FDA says the guidance applies to new drugs, therapeutic proteins and recombinant/plasma-derived blood proteins regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) but does not apply to cell and gene therapies, adjuvanted vaccines or other types of biologics.
“The extent of the effects on the immune system should be adequately characterized to properly inform the overall risk-benefit of the product,” FDA writes.
FDA also reminds sponsors to, “to the extent practicable, follow existing guidance on placing immunotoxicology studies in the electronic common technical document (eCTD) format.”
The guidance is broken up into three main sections, the first two discuss approaches to assessing the potential for products to reduce or increase immune system activity, while the third section provides considerations for developmental and juvenile animal studies.
FDA, Federal Register Notice


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