Introduction and inspiration of FDA's Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs Draft Guidance for Industry
Introduction and inspiration of FDA's Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs Draft Guidance for Industry
FDA issued the Content and Format of Composition Statement and Corresponding Statement ofIngredients in Labeling in NDAs and ANDAs Draft Guidance for Industry in April 2024.This guidance provides a detailed and specific introduction to the best writing method for drug composition statements in pharmaceutical application materials and corresponding ingredient statements in labelings.Listed common problems and provided recommendations to avoid them.The guidance also provides examples of standardized writing at the end,making the best writing method clear at a glance.However,there is currently no similar guidance in China.This article provides a detailed introduction to the FDA's guidance,hoping to be helpful for the standardized writing of these two aspects for drug researchers in China,and also provide inspiration for the corresponding review of drug regulatory departments in China.
关键词
美国食品药品管理局(FDA)/新药申请和仿制药申请/组成说明/成分说明/说明书/指导原则
Key words
Food and Drug Administration(FDA)/NDA and ANDA/composition statement/statement of ingredients/labeling/guidance
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