M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes September 2015

GUIDANCE DOCUMENT

• Docket Number: FDA-2013-S-0610
• Issued by: Center for Drug Evaluation and Research

 

M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk   Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes

 

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. 

 

 

 

For questions regarding this draft document, contact (CDER) Aisar Atrakchi 301-796-1036 or (CBER) Anne Pilaro 240-402-8341.

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