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Imprese · 09/09/20151 min di lettura
Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability
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Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Nonclinical Evaluation of Endocrine-Related Drug Toxicity." The purpose of this guidance is to clarify when additional studies are warranted after the standard toxicology tests have been conducted and there is a signal for potential adverse endocrine-related toxicity. This guidance finalizes the draft guidance entitled "Endocrine Disruption Potential of Drugs: Nonclinical Evaluation" issued on September 20, 2013.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →