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International Conference on Harmonization

This article was originally published in The Tan Sheet

Executive Summary

Comments on draft guidance entitled "Electronic Common Technical Document Specification" requested by FDA in Nov. 28 Federal Register notice. Document outlines means for electronically submitting regulatory information to agency in way that will "facilitate [its] creation, review, life cycle management and archiving." Comments are due within 90 days...

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International Conference on Harmonization

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