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ICH Consults On Standardizing Benefit-Risk Information In CTD Drug Submissions

This article was originally published in SRA

Executive Summary

The International Conference on Harmonisation is inviting feedback on proposed changes to how drug companies should present the benefits and risks of their drug in Module 2 of the common technical document (CTD)1,2. The proposed changes aim to standardize the presentation of benefit-risk information in regulatory submissions using the CTD format.


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