Harmonized labeling next step after ICH common technical document -- FDA's Woodcock.

Executive Summary

STANDARDIZED DRUG LABELING INDICATIONS IN U.S., EU AND JAPAN will be the next step toward a common International Conference on Harmonization review format after the common technical document is complete, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told the recent Drug Information Association annual meeting in Boston. "There would have to be more harmonization of the indications" before regulating bodies in the U.S., the European Union and Japan could use a common review format, Woodcock said. "That is something that there is no formal process for."