Guidance for Industry and Review Staff on Recommended Approaches to Integration of Genetic Toxicology Study Results; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and review staff entitled "Recommended Approaches to Integration of Genetic Toxicology Study Results." This guidance is intended to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in genetic toxicology assays during drug development. The guidance provides recommendations on how to proceed with clinical studies while ensuring the safety of study participants when results in genotoxicity studies suggest a potential cancer or genetic hazard.