The vision of having a product quality dashboard that would help guide FDA in regulating drug product lifecycles is emerging into more concrete form as the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) begins its second year.
The dashboard is being designed to provide a comprehensive summary of the current state of quality for new and abbreviated new drug applications (NDAs/ANDAs) for a particular drug product.
At the IFPAC Forum on Process Analytical Technology in Arlington, Virginia in late January, Acting Director of OPQ’s Office of Lifecycle Drug Products (OLDP) Susan Rosencrance explained how the dashboard is taking shape and how it fits in with FDA’s evolving quality regulatory processes.
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