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



## Minuteman (Feb 15, 2011)

*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/#!documentDetail;D=FDA-2015-D-2001-0001

Excerpt:



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 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessment of Male-Mediated Developmental Risk for Pharmaceuticals." This draft guidance provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient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


----------

