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FDA joins novel coronavirus counter-efforts with moves to expedite medical options

The U.S. Food and Drug Administration (FDA) has joined the international effort to fight the Wuhan coronavirus — a novel coronavirus known as 2019-nCoV — through assistance to developers, a public information campaign and diagnostics development.

“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,” Dr. Stephen Hahn, FDA Commissioner, said. “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.”

With five confirmed cases of 2019-nCoV in the United States and dozens more being investigated, the viral threat demands cooperation to meet effectively. With that in mind, the FDA intends to work with interagency partners, product developers, international partners, and global regulators.

Information will be critical going forward — much misinformation is already spreading surrounding the 2019-nCoV. To assist its partners, the FDA will share updates on processes currently in place to help developers better navigate and advance any medical countermeasures. The administration has also launched a landing page dedicated to the novel coronavirus, with crucial information for the public and updates on FDA response efforts.

“We are committed to keeping the American people informed as we prepare and respond to emerging public health threats, including the novel coronavirus,” Anna Abram, FDA Deputy Commissioner of Policy, Legislation and International Affairs, said. “The agency is committed to ensuring safe and effective medical countermeasures are available as quickly as possible to protect public health.”

There are currently no commercially available products capable of detecting the novel coronavirus. Still, part of the FDA’s focus will be on facilitating the development of diagnostics capable of doing so. It is also working with public health partners to share reference materials necessary for such developments.

Chris Galford

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