- Docket Number:
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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
For questions regarding this draft document, contact (CDER) Aisar Atrakchi 301-796-1036 or (CBER) Anne Pilaro 240-402-8341.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-S-0610 .