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Guidance on Fetal Risk from APIs Administered to Males


Federal Register Notice: FDA is making available a draft guidance for industry entitled Assessment of Male-Mediated Developmental Risk for Pharmaceuticals. It provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient to males either through an effect on the male germ cell or from fetal exposure following seminal transfer of a potentially developmental toxicant to pregnant females. The need for measures to mitigate the risk to embryo/fetal development posed by males participating in clinical trials is also addressed. To download this guidance, click here. To view this notice, click here.