CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight. Jun 02, 2019 By Jill Wechsler Pharmaceutical Technology Volume 43, Issue 6, pg 14, 38 As part of its ongoing efforts to ensure the availability of high-quality medicines, FDA’s Center for Drug Evaluation and Research (CDER) is rolling out a new system to enhance the evaluation of prescription drug attributes, risks, and control strategies. The Knowledge-aided Assessment and Structured Application (KASA) initiative aims to improve the efficiency, consistency, and objectivity of regulatory quality assessment by collecting structured data on drug substance, product design, and manufacturing process to better assess inherent risks and how they are controlled. CDER’s Office of Pharmaceutical Quality (OPQ) is piloting the program first for abbreviated new drug applications (ANDAs) for generics, with the aim of rolling out the system to generic solid oral dosage forms by year-end. Next will come generic liquids and injectables, followed by new drugs and biologics. Click Here For Complete Article Text
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