International Conference on Harmonization
Executive Summary
Publishes two final and two draft guidelines in the Sept. 22 Federal Register. The final guidelines cover "Stability Testing of New Drug Products and Substances" and "Detection of Toxicity to Reproduction for Medicinal Products"; the draft guidelines address "Specific Aspects of Regulatory Genotoxicity Tests" and "Impurities in New Drug Substances." The comment period for the draft guidelines extends until Dec. 6