Novel coronavirus (2019-nCoV)

FDA is working with U.S. Government partners, including the U.S. Centers for Disease Control and Prevention (CDC), and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

On January 27, 2020, FDA announced critical actions to advance development of novel coronavirus medical countermeasures.

As with any emerging public health threat, FDA is collaborating with interagency partners, product developers, international partners, and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks.

Learn more: 2019-nCoV updates from FDA

Related links:

Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak, from the FDA Center for Biologics Evaluation and Research (CBER) (February 4, 2020)
For more updates from FDA, follow @SteveFDA, @US_FDA, @FDA_Global, and @FDA_MCMi on Twitter
2019 Novel Coronavirus (CDC)
Secretary Azar Declares Public Health Emergency for United States for 2019 Novel Coronavirus (HHS) (January 31, 2020)
Also see EUA updates and Information for industry below

What's new

February 4, 2020: FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic - FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country. Additional technical information and fact sheets
February 4, 2020: Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak - The potential for transmission of 2019-nCoV by blood and blood components is unknown at this time. However, respiratory viruses, in general, are not known to be transmitted by blood transfusion, and there have been no reported cases of transfusion-transmitted coronavirus. Routine blood donor screening measures that are already in place should prevent individuals with clinical respiratory infections from donating blood. As a precaution, blood establishments may wish to consider whether to provide donor education, encourage self-deferral, and manage post-donation information about 2019-nCoV. Read more
January 27, 2020: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures - “We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”
January 27, 2020: FDA requests that diagnostic test sponsors interested in potential Emergency Use Authorization (EUA) for tests to detect 2019-nCoV contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates. Also see: How to Submit a Pre-EUA for In vitro Diagnostics to FDA