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Negócios · 09/09/20151 min de leitura
Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability
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Resumo
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 This guidance finalizes the draft guidance entitled "Endocrine Disruption Potential of Drugs: Nonclinical Evaluation" issued on September 20, 2013.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →