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Zdrowie i gospodarka · 26.03.2008

International Conference on Harmonisation; Draft Guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines information from two ICH guidances, "S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals" and "S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals." The draft guidance is intended to help facilitate drug development programs, ensure patient safety, and reduce animal usage.

Source: Federal Register — Food and Drug AdministrationOpen original release →