FDA draft guidance on clinical studies in the presence of genetic toxicology.(Regulatory Update)(Brief Article)

In the Dec. 2, 2004, Federal Register, FDA announced the availability of a draft guidance for industry titled, Recommended Approaches to Integration of Genetic Toxicology Study Results. This draft guidance is intended to inform industry on how the Center for Drug Evaluation and Research (CDER) views positive findings in genetic toxicology assays, and to provide recommendations to industry on how to proceed in ensuring safety of healthy subjects or patients when results in genotoxicity studies suggest a potential cancer or genetic hazard. Risk for carcinogenesis usually is determined in rodent assays, in either two-year studies or shorter-term studies using alternative models. …