In August 2011, FDA released a draft guidance for industry on “Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation” for a 90-day public comment period.
The guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met to facilitate the evaluation and labeling of tablets that have been scored. A scoring feature, the draft notes, facilitates the practice of tablet splitting.
Specifically, the guidance recommends: ● guidelines to follow, data to provide, and criteria to meet and detail in an application to approve a scored tablet, and ● nomenclature and labeling for approved scored tablets. The guidance does not address specific finished-product release testing, where additional requirements may be appropriate for scored tablets.