Zdrowie i gospodarka · 25/07/2023

FDA Releases Final Guidance on DNA Reactive Impurities in Pharmaceuticals

The FDA has released a final guidance document, M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, to harmonize the assessment and control of DNA reactive impurities in pharmaceuticals, replacing the previous M7(R1) guidance.