Friday 30 October 2020

FDA issues mutagens guidance


ICH M7 Guideline: assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk- Q&A FDA has now formally published this Q&A as draft guidance for comment by 27 Nov.2020.

Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities.

This Question and Answer (Q&A) document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorization applications and/or Master Files.

The scope of this Q&A document follows that of ICH M7.



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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