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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of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers Draft Guidance for Industry September 2020

Download the Draft Guidance Document
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2020-N-1790
Issued by:
Guidance Issuing Office
Center 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

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All written comments should be identified with this document's docket number: FDA-2020-N-1790.

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