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Summary bridging and addendum reports confirmed dead in ICH benefit-risk reporting guideline

This article was originally published in SRA

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Executive Summary

Summary bridging and addendum reports are categorically not needed under the new international guideline on periodic reporting of a drug's benefit-risk profile - E2C(R2) - according to a senior participant in the guideline development process.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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