1. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023 Subject(s): CarcinogensDrug Contamination -- prevention & controlDrug DevelopmentDrug IndustryGovernment RegulationMutagenicity TestsMutagensUnited StatesUnited States. Food and Drug Administration
