International Conference on Harmonisation; guidance on ethnic factors in the acceptability of foreign clinical data; availability--FDA. Notice.
The Food and Drug Administration (FDA) is publishing a guidance entitled "E5 Ethnic Factors in the Acceptability of Foreign Clinical Data". The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance recommends regulatory and development strategies to permit clinical data collected in one region to be used for the support of drug and biologic registrations in another region while allowing for the influence of ethnic factors.
D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007391:International Cooperation; D014481:United States; D014486:United States Food and Drug Administration