Last week’s round-up, 19-23 August 2019

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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Elemental impurities

Real Generics’ Regulatory News Digest For Generics – 10 August 2015

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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