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ICH INVESTIGATOR BROCHURE FINAL GUIDELINE INCLUDES SAFETY/EFFICACY SUMMARIES ACROSS TRIALS; FINAL ICH IMPURITIES GUIDELINE UNCHANGED FROM DRAFT

Executive Summary

Summaries of safety and efficacy data for products with a large number of clinical trials are recommended in the International Conference on Harmonization's final guideline on "Good Clinical Practice: Guideline for the Investigator's Brochure."
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