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FDAnews Drug Daily Bulletin
July 6, 2012 | Vol. 9 No. 132
Final Genotoxicity Test Guidance Should Improve Risk Characterization
The FDA has revised its guidance on testing a new drug’s genotoxicity to help drugmakers optimize the standard genetic toxicology battery and better predict potential human risks. The agency guidance also gives advice on interpreting test results, including assessing nonrelevant findings. The final guidance, which replaces a 2008 draft, should improve risk characterization of carcinogenic effects that have their basis in changes in genetic material, the agency said.
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