FDA Guidance for Industry: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
Title:
FDA Guidance for Industry: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
Origin/Publisher:
FDA
Content:
This 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.