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비즈니스 · 2015. 9. 9.1 분 읽기
Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability
로컬 자동 번역 · 원본 출처 언어
요약
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 This guidance finalizes the draft guidance entitled "Endocrine Disruption Potential of Drugs: Nonclinical Evaluation" issued on September 20, 2013.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →