GUIDANCE DOCUMENT
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers Draft Guidance for Industry September 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-N-1790
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
M7 Implementation Working Group
ICH M7 Guideline: ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK
Questions and Answers
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
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-N-1790.