2021 Annual Report Now Available from FDA OCP’s Division of Applied Regulatory Science

FDA OCP Division of Applied Regulatory Science 2021 Annual Report Now Available

2021 Annual Report Now Available from FDA OCP's Division of Applied Regulatory Science The Food and Drug Administration (FDA) Office of Clinical Pharmacology's Division of Applied Regulatory Science (DARS) announces the availability of the 2021 DARS Annual Report. In 2021, DARS staff engaged stakeholders in collaborative, mission-critical research and review activities related to the safety and effectiveness of COVID-19 therapies, opioids and opioid reversal agents, and widely used over-the-counter drugs such as ranitidine and sunscreens. Additional projects focused on medications for all ages, including pediatrics and geriatrics, antibiotic resistance, drug-drug interactions, generic drugs and biosimilars, and rare diseases. DARS staff advanced the science, policy and regulatory application of laboratory, computational and clinical drug development tools both at FDA and internationally, including leading the development of an International Council for Harmonisation (ICH) regulatory guideline for cardiac safety and convening a public workshop on pharmacodynamic biomarkers for biosimilars. DARS achieves its mission of bridging scientific innovation and drug review by performing critical research and expert regulatory review consultations to fill regulatory knowledge gaps, enhance drug development, and facilitate review. DARS activities span the spectrum of translational research, including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and post-market analyses. Learn more about how DARS uses translational research to advance regulatory science and improve public health by visiting the FDA DARS website. 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 at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and 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.

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