Zdrowie i gospodarka · 13/03/2013

Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation." This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or cutting a higher-strength tablet into smaller portions.) Specifically, this guidance recommends guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet; and nomenclature and labeling for approved scored tablets. This guidance does not address specific finished-product release testing, where additional requirements may apply to scored tablets. This guidance does not describe the medical practice conditions under which tablet splitting is considered or recommended.