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FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals

August 1, 2023


The M7 (R2) guidance emphasizes the importance of safety and risk management in creating levels of mutagenic impurities that are anticipated to not pose significant carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that live in (or are anticipated to live in) final drug substance or product, with consideration for the planned conditions of human use.

The guidance highlights considerations for marketed products, including post-approval changes to the drug substance chemistry, manufacturing, and controls, and changes to the clinical use of marketed products. It also contains a drug substance and drug product impurity assessment, touching on synthetic impurities, degradation products, and considerations for clinical development.

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