美国食品药品监督管理局（FDA）于2015年6月发布了《药物雄性介导发育毒性风险评估指导原则》（草案），阐述了当前FDA对男性人群使用药物后产生的潜在相关发育毒性风险评估的策略与方法，拓展了对传统雄性生殖与发育毒性的认识与评价。该指导原则对于指导研究者进行药物临床和非临床雄性生殖与发育毒性评价具有重要意义，而我国目前对此类毒性风险尚未特殊关注。简介该指导原则主要内容，以供研究者参考。

FDA issued Assessment of Male-Mediated Developmental Risk for Pharmaceuticals Guidance for Industry (draft) in June 2015. This guidance provides strategies and methods for assessing risks to embryo/fetal development resulting from administration of an investigational active pharmaceutical ingredient (API) to males and expanding the traditional recognizing for male reproductive and developmental toxicity. This guidance is of great significance to guide the clinical and non-clinical studies on evaluation of male reproductive and developmental toxicity. However, in China, male-mediated developmental risk has not yet been concerned specially. This article introduces the guidance to provide recommendations for researchers.

浙江省科技计划项目（2014F30018）