FDA Issues Draft Guidance to Industry on Tablet Scoring
The FDA has issued a draft of guidance to the pharmaceutical industry on Tablet Scoring: Nomenclature, Labelling, and Data for Evaluation.
The FDA has issued a draft of guidance to the pharmaceutical industry on Tablet Scoring: Nomenclature, Labelling, and Data for Evaluation.The guidelines are prepared by the Centre for Drug Evaluation and Research (CDER) at the USFDA. The regulatory major is seeking comments before 90 days which is by November end.
The guidance provides recommendations to sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) regarding on the criteria to be met to facilitate the evaluation and labelling of tablets that have been scored. A scoring feature facilitates the practice of tablet splitting.
The guidance does not address specific finished-product release testing, where additional requirem
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