Zdrowie i gospodarka · 29/09/2020

FDA Releases Draft Guidance on DNA Reactive Impurities in Pharmaceuticals

The US Food and Drug Administration (FDA) has released a draft guidance document titled 'M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk--Questions and Answers' to help industry implement the ICH M7 Guideline and address requests for clarification on mutagenic impurities. The document aims to provide a practical approach to identifying, categorizing, and controlling mutagenic impurities to minimize carcinogenic risk.