Regional bridging studies may be unnecessary for "ethnically insensitive" drugs -- ICH guidance.

Executive Summary

ETHNIC BRIDGING DATA MAY BE UNNECESSARY, ICH GUIDANCE suggests, when a drug's activity is not sensitive to ethnicity or a geographic region's experience with pharmacologically related compounds makes extrapolation of clinical data feasible. The International Conference on Harmonization draft guidance on "Ethnic Factors in the Acceptability of Foreign Clinical Data," published in the July 31 Federal Register, outlines "regulatory and development strategies that will permit adequate evaluation of the influence of ethnic factors while minimizing duplication of clinical studies and expediting the drug approval process," FDA wrote. FDA will accept comments on the document through Oct. 29.