M7(R1): Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``M7(R1): Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' This guidance updates and replaces the May 2015 guidance for industry ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' This guidance finalizes the draft guidance ``M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk,'' issued September 28, 2015 (80 FR 58261). The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This M7(R1) document provides guidance on acceptable intakes (AIs), or permissible daily exposures (PDEs), derived for some chemicals that are considered to be mutagens and carcinogens and, are also commonly used in the synthesis of pharmaceuticals or are, useful examples to illustrate the principles for deriving compound-specific intakes described in ICH M7. This document is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.