The Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.” This draft guidance provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient (API)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.
The Teratology Society will be preparing comments on the draft guidance. This will be done through the Public Affairs Committee (PAC) with input from individual members and approval by Council.
Please add your comments on the draft guidance below using the Comment function (you must be logged in to BDR Connection). The final date for comments to be submitted for consideration/inclusion is July 17.
If you would like to participate in the PAC's discussion about the draft guidance and the development of the Society's comments, please contact PAC Chair Chris Lau as soon as possible.
More details may be found on the Federal Register.