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

Published: July 25, 2023

M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk

Source: fda.gov

Related Topics:

Guidance Issuing OfficeDrug AdministrationDocket NumberDrug EvaluationBiologics EvaluationLimit Potential CarcinogenicCompound Specific AcceptableLimit Potential Carcinogenic Risk QuestionsInternational CouncilTechnical RequirementsHuman Use

M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE

Published: July 24, 2023

Addendum to M7(R2)

Source: fda.gov

Related Topics:

Drug AdministrationGuidance Issuing OfficeDocket NumberDrug EvaluationBiologics EvaluationLimit Potential CarcinogenicCompound Specific AcceptableLimit Potential Carcinogenic Risk QuestionsInternational CouncilTechnical RequirementsHuman Use

M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities i

Published: July 24, 2023

M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers

Source: fda.gov

Related Topics:

Guidance Issuing OfficeDrug AdministrationDocket NumberDrug EvaluationBiologics EvaluationLimit Potential CarcinogenicCompound Specific AcceptableLimit Potential Carcinogenic Risk QuestionsInternational CouncilTechnical RequirementsHuman Use