Guidance on Reproductive and Developmental Toxicity Studies for Human Pharmaceuticals

In May 2021, FDA published “S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals - Guidance for Industry” This guidance is intended to help drug developers plan and evaluate nonclinical developmental and reproductive toxicity studies necessary to support human clinical trials and marketing authorization for pharmaceuticals. The 2021 revisions to this guidance describe testing strategies utilizing alternative assays for the assessment of malformations and embryofetal lethality. The guidance also provides basic principles that will assist in the development, qualification, and potential regulatory use of alternative assays for evaluating adverse effects on embryofetal development.