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GUIDANCE DOCUMENT

E5 Ethnic Factors in the Acceptability of Foreign Clinical Data June 1998

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1997-D-0360
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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).

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1997-D-0360.

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