FDA seeking comments: "Male-Mediated Developmental Risk for Pharmaceuticals". - Mothering Forums

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#1 of 1 Old 06-25-2015, 09:07 PM - Thread Starter
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FDA seeking comments: "Male-Mediated Developmental Risk for Pharmaceuticals".

In case any readers have knowledge or expertise in this area. The deadline for comments is 11 August 2015.




The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.” This draft guidance provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient (API) 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.
Current regulatory guidance exists regarding the need to assess the genotoxic and embryo/fetal developmental toxicity potential of pharmaceuticals before their administration to pregnant women and females of reproductive potential. However, there is a lack of consistency in clinical trial protocol designs and labeling documents regarding pregnancy risk for sexual partners of men being administered an API.
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