Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 9.9.20151 Min. Lesezeit
Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
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 This guidance finalizes the draft guidance entitled "Endocrine Disruption Potential of Drugs: Nonclinical Evaluation" issued on September 20, 2013.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →