title: Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.
abstract: 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.
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
authors: Adam C
authors: AC
authors: Fisher
authors: 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.
authors: Sau L
authors: SL
authors: Lee
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
authors: Daniel P
authors: DP
authors: Harris
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
authors: Lucinda
authors: L
authors: Buhse
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
authors: Steven
authors: S
authors: Kozlowski
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
authors: Lawrence
authors: L
authors: Yu
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States.
authors: Michael
authors: M
authors: Kopcha
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
authors: Janet
authors: J
authors: Woodcock
mesh_terms: D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D012106:Research / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations
keywords: Emerging technology; Pharmaceutical quality; Policy; Quality standards; Regulatory science