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FDA Oncology Center of Excellence During COVID-19—Working for Patients With Cancer

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

In January 2020, coronavirus disease 2019 (COVID-19) emerged as an urgent global public health crisis. This pandemic represents an immediate risk to patients with cancer because of the infection itself and the resultant modifications to cancer treatment regimens. COVID-19 has also had disruptive effects on clinical trial conduct, potentially impacting current and future patients. In addition, the pandemic poses risks to healthy individuals owing to delayed screenings.

Despite pandemic-related challenges, the US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) remains committed to its public health mission, which includes addressing the needs of US patients with cancer. Herein, we present an overview of the progress FDA oncology staff have made since the start of COVID-19.1

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Article Information

Corresponding Author: Jennifer J. Gao, MD, Oncology Center of Excellence, US Food and Drug Administration, 10903 New Hampshire Ave, WO 22/2135, Silver Spring, MD 20993 (jennifer.gao@fda.hhs.gov).

Published Online: December 23, 2020. doi:10.1001/jamaoncol.2020.6783

Conflict of Interest Disclosures: None reported.

Additional Contributions: We greatly acknowledge the assistance of our colleagues at the US Food and Drug Administration (FDA) who contributed to the creation and editing of this article: Kirsten Goldberg, MA, FDA Oncology Center of Excellence (OCE); Laleh Amiri-Kordestani, MD, FDA Division of Oncology 1; Amna Ibrahim, MD, FDA Division of Oncology 1; Harpreet Singh, MD, FDA Division of Oncology 2; Martha Donoghue, MD, FDA Division of Oncology 2; Steven Lemery, MD, FDA Division of Oncology 3; Ibilola Fashoyin-Aje, MD, FDA Division of Oncology 3; R. Angelo De Claro, MD, Division of Hematologic Malignancies 1; Nicole Gormley, MD, Division of Hematologic Malignancies 2; Paul Kluetz, MD, FDA OCE; Marc Theoret, MD, FDA OCE; and Julia Beaver, MD, FDA OCE. None received compensation for this assistance.

References
1.
US Food and Drug Administration. Oncology Center of Excellence. Accessed July 27, 2020. http://www.fda.gov/about-fda/fda-organization/oncology-center-excellence
2.
US Food and Drug Administration. COVID-19-related guidance documents for industry, FDA staff, and other stakeholders. US Food and Drug Administration. Accessed July 27, 2020. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders
3.
US Food and Drug Administration. Project Orbis. Accessed December 5, 2019. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
4.
US Food and Drug Administration. Drugs@FDA: FDA-approved drugs. Accessed June 2, 2020. https://www.accessdata.fda.gov/scripts/cder/daf/
5.
US Food and Drug Administration. Project Facilitate. Accessed July 27, 2020. https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate
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