Author: [AUTHOR] Published on 3/3/2023 6:00:00 AM
FDA Office of Clinical Pharmacology Announces Availability of 2022 Division of Applied Regulatory Science Annual Report
The US Food and Drug Administration (FDA), Office of Clinical Pharmacology (OCP), Division of Applied Regulatory Science (DARS) announces the availability of the
2022 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. DARS moves new science into the FDA regulatory process and addresses emergent public health needs.
The 2022 DARS Annual Report highlights the Division’s unique position to engage stakeholders to conduct mission-critical applied laboratory, computational, and clinical research. In 2022, DARS staff led research and review activities to address multiple complex regulatory issues and public health questions, including the safety and efficacy of COVID-19 therapies, safe use of prescription opioids and treatment of opioid overdose, as well as advancing the use of biomarkers for biosimilar drug development.
For more details on DARS and their diverse functional capabilities, dedicated and collaborative culture, achievements, and 2023 outlook, visit the
2022 DARS Annual Report.
To access past DARS annual reports and learn more about DARS, visit the
DARS webpage.
The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest.
Subscribe today or click the button below select Clinical Pharmacology Corner under Drugs.
We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to
ocp@fda.hhs.gov.
This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
