ETS 2024 -- In December 2017, the U.S. Food and Drug Administration (FDA) requested the four gadolinium-based contrast agent (GBCA) NDA holders to further investigate the effects of gadolinium (Gd) retention on fetal and neonatal development in mice and juvenile nonhuman primates (NHP) to evaluate the potential effect of GBCAs on behavioral, neurological and histopathological changes. The studies performed in mice have been previously presented and the results of the NHP study are presented here.

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