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.

http://www.regulations.gov/#!documen...15-D-2001-0001

Excerpt:

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Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.” This draft guidance provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient (API)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.
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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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