GUIDANCE DOCUMENT
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
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2013-S-0610
- Issued by:
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Guidance Issuing OfficeCenter 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
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This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.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.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-S-0610 .