Zdrowie i gospodarka · 28/05/2015

FDA Releases Guidance on DNA Reactive Impurities in Pharmaceuticals

The Food and Drug Administration (FDA) has released a guidance document titled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, developed under the International Conference on Harmonisation (ICH), to help pharmaceutical companies manage mutagenic impurities in their products and minimize carcinogenic risk. The guidance provides recommendations for assessing and controlling mutagenic impurities in new drug substances and products during clinical development and marketing applications.