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®: CRE Regulatory Action of the Week

FDA Seeks Comment on Genetic Toxicology Guidance
The Food and Drug Administration seeks public comment on draft agency guidance entitled "Recommended Approaches to Integration of Genetic Toxicology Study Results." The FDA explains in its Federal Register notice, "This draft guidance is intended to inform industry on how the Center for Drug Evaluation and Research (CDER) views positive findings in genetic toxicology assays, and to provide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 assuring safety of health subjects or patients when results in genotoxicology studies suggest a potential cancer or genetic hazard." Comments are due by January 31, 2005.

  • Click for FDA solicitation of comments on draft guidance.