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
Guidance Issuing Office Drug Administration Docket Number Drug Evaluation Biologics Evaluation Limit Potential Carcinogenic
Source: fda.gov