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In Brief: ICH draft guidelines

This article was originally published in The Tan Sheet

Executive Summary

ICH draft guidelines: FDA publishes International Conference on Harmonization draft guideline on "Structure and Content of Clinical Study Reports" in Aug. 23 Federal Register. Comments on the draft guideline, which is intended to facilitate the compilation of a single worldwide submission for pharmaceuticals to regulatory bodies, are due by Oct. 10. The agency also publishes in Aug. 21 Federal Register draft guidelines on "Conditions Which Require Carcinogenicity Studies for Pharmaceuticals" and "Detection of Toxicity to Reproduction: Addendum on Toxicity in Male Fertility"...
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