Zdrowie i gospodarka · 12/06/2015

FDA Announces Draft Guidance on Assessing Male-Mediated Developmental Risk in Pharmaceuticals

The Food and Drug Administration (FDA) has released a draft guidance for industry on assessing risks to embryo/fetal development from pharmaceuticals administered to male participants in clinical trials, with the goal of mitigating these risks.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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