Zdrowie i gospodarka · 22.09.1994
International Conference on Harmonisation; Draft Guideline on Specific Aspects of Regulatory Genotoxicity Tests; Availability
The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Notes for Guidance on Specific Aspects of Regulatory Genotoxicity Tests.'' This guideline was prepared by the Safety Expert Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guideline is intended to provide guidance on genotoxicity testing. DATES: Written comments by December 6, 1994.