Guidance for Industry M7 R2 Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk

Guidance for Industry M7 R2 Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk. M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The guidance and supplemental documents are intended to harmonize the considerations for assessment and control of DNA reactive (mutagenic) impurities.