By Tessa Fiorini-Cohen and Marthese Mifsud Administrative Law Overview | RAPS 23 Aug 2019 A comprehensive overview of the United States’ federal administrative processes as related to regulatory affairs has recently become available on RAPS. The publication explains the Federal Register, Code of Federal Regulations, and the Administrative Procedures Act through which stakeholders can […]
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Draft ICH Guidelines for Consultation Mutagenic impurities ICH has released a draft addendum to ICH Guideline M7 on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The addendum summarises known mutagenic impurities commonly found or used in drug synthesis (e.g. aniline, dimethyl sulfate, ethyl chloride, hydroxylamine), providing acceptable […]
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