FDA’s implementation of knowledge-aided assessment and structured application for manufacturing assessment of non-sterile solid oral dosage form drug products

FDA’s implementation of knowledge-aided assessment and structured application for manufacturing assessment of non-sterile solid oral dosage form drug products

Abstract The Knowledge-Aided Assessment and Structured Application (KASA) is an initiative led by the FDA’s Center for Drug Evaluation and Research (CDER) which is launched within CDER’s Office of Pharmaceutical Quality (OPQ). It is a platform designed to conduct the quality assessment of drug product applications more efficiently, effectively, and consistently, promoting OPQ’s “One Quality Voice”. KASA is part of CDER’s broader efforts to suppo…