International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) line M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk ...
FDA Signs onto ICH Guidance on E3
继ICH E3问答于2012年7月发布之后，FDA于日前发布关于ICH E3的问答指南（Guidance for Industry E3 Structure and Content of
Clinical Study Reports - Questions and Answers (R1)），该Q&A澄清了E3中的关键问题，包括7个问答。
FDA Guid...
