FDA Issues FY2023 Report on the State of Pharmaceutical Quality

https://www.fda.gov/media/179254/download?attachment=&utm_medium=email&utm_source=govdelivery FDA is announcing the fiscal year 2023 Report on the State of Pharmaceutical Quality from the Office of Pharmaceutical Quality (OPQ). The mission of OPQ in FDA’s Center for Drug Evaluation and Research is to assure that quality medicines are available for the American public. In this report, OPQ analyzes FDA-registered drug manufacturers and drugs, including biological products regulated by CDER, to inform stakeholders about the quality of the U.S. drug supply. In addition to analyses and insights about drug manufacturers and their products, this report: Highlights the advancement of CDER’s quality oversight through implementation of the CARES Act Drug Amount Reporting Program and the development of a Quality Management Maturity Program. Describes new approaches, such as quantitative measures of natural hazards, to help FDA and its stakeholders better prevent or mitigate quality issues that may lead to supply chain vulnerability and drug shortages in a changing environment. Presents reasons for new drug shortages that occurred during calendar years 2022 and 2023. Provides data on recalls and global trends in quality and product failures. Shares findings from a recent assessment of the public health value of requests for records and other information under the Federal Food, Drug, and Cosmetic Act.