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In Brief: ICH guideline

This article was originally published in The Tan Sheet

Executive Summary

ICH guideline: Availability of a draft guideline on good clinical practices is announced by FDA in the Aug. 17 Federal Register. The draft guideline, which reached Step 4 of the International Conference on Harmonization process in May, is intended to "provide a unified standard for designing, conducting, recording and reporting trials." FDA is seeking comments on the draft guideline by Oct. 2...
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