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ビジネス · 2015/9/91 分で読めます

Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability

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概要

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 This guidance finalizes the draft guidance entitled "Endocrine Disruption Potential of Drugs: Nonclinical Evaluation" issued on September 20, 2013.

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

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