The FDA Office of Clinical Pharmacology’s Division of Applied Regulatory Science Announces Availability of Its 2025 Annual Report

https://www.fda.gov/media/191276/download?attachment=&utm_medium=email&utm_source=govdelivery Today, the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Division of Applied Regulatory Science (DARS) announced the availability of the 2025 DARS Annual Report. As OCP’s dedicated research division, DARS specializes in the application of translational approaches such as in vitro and in vivo laboratory methods, experimental medicine, in silico computational modeling and informatics, and integrated clinical research to meet regulatory and public health challenges. The accomplishments described in this year’s report reflect DARS’s commitment to enhance public health and address emerging issues through applied regulatory science. The dedication of a highly collaborative and expert staff, working with a broad range of stakeholders, delivered new review and drug development tools to support decision-making. For more details on DARS’s scientific contributions to regulatory science and public health, read the 2025 DARS Annual Report. To learn more about DARS, visit the DARS webpage.