E5 Ethnic Factors in the Acceptability of Foreign Clinical Data

Issue Date: June 10, 1998
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final

E5 Ethnic Factors in the Acceptability of Foreign Clinical Data

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).

Download the Guidance Document