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EMA developing principles on when to 'go broader or narrower' in indication wording

This article was originally published in SRA

Executive Summary

The European Medicines Agency is developing general principles on the wording that drug makers may apply to indicate in which populations their drugs can be used. The "indication wording" initiative will particularly focus on when the population may be broader or narrower compared to the study population investigated in the clinical trials supporting the marketing authorization application for the drug1.