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."