# Guidance for Industry | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/guidance-for-industry-m7r2-assessment-and-control-of-dna-reactive-mutagenic-impurities-in-pharmaceuticals-to-limit-potential-carcinogenic-risk/90470c75-0c9c-4b55-a4dd-bb7a0d572e79

> FDA guidance document: Guidance for Industry | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk. Issue date: July 25, 2023. Get complete insights and analysis.

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## Details

- Title: Guidance for Industry | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-07-25
- Last Changed: 2023-07-25
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-0055">FDA-2022-D-0055</a>

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