Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.
Adam C Fisher, Sau L Lee, Daniel P Harris, Lucinda Buhse, Steven Kozlowski, Lawrence Yu, Michael Kopcha, Janet Woodcock
Author Information
Adam C Fisher: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
Sau L Lee: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States. Electronic address: sau.lee@fda.hhs.gov.
Daniel P Harris: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
Lucinda Buhse: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
Steven Kozlowski: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
Lawrence Yu: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
Michael Kopcha: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
Janet Woodcock: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public.
