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FDA News: Issue 9, April 2021

Author: [AUTHOR] Published on 4/21/2021 4:30:00 PM


FDA Office of Clinical Pharmacology Announces Availability of the 2020 DARS Annual Report

he Food and Drug Administration (FDA) Office of Clinical Pharmacology’s Division of Applied Regulatory Science (DARS) announces the availability of the 2020 DARS Annual Report. 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. In addition, DARS staff conduct research to address unanswered, critical public health questions, such as whether sunscreen ingredients are systemically absorbed, and whether drugs can form carcinogens in patients.

The 2020 DARS Annual Report highlights how DARS staff apply translational research to inform drug safety, facilitate the development of complex generics and biosimilars, and assess regulatory use of novel drug development tools and approaches. This report describes the Division’s expanded clinical trial operations, cross-cutting programs in cardiac safety, opioids, biosimilars, and generics, as well as consults and reviews related to investigational drugs for COVID-19.

Learn more about how DARS uses translational research to advance regulatory science and improve public health by reading the 2020 DARS Annual Report here: https://go.usa.gov/xHb7Q. Past DARS annual reports can be found at: https://go.usa.gov/xHb7E.


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 http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) 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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