FDA is gearing up to deal with the looming threat of the 2019 novel coronavirus (nCoV) and in some cases, if the need presents itself, could employ the use of the Emergency Use Authorization (EAU) Pathway.
On Monday, the federal agency revealed it had put together a strategy that will see it working 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 outbreaks.
"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," FDA Commissioner Stephen M. Hahn, M.D., said in a release. "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."
As part of FDA's ongoing commitment to prepare and respond to infectious disease outbreaks, the agency is sharing updates on processes in place to help developers understand the pathways, including EUA, that may be available to more rapidly advance and make medical countermeasures available for this virus, including diagnostic tests.
FDA said it has launched a landing page that provides key information for the product developers and the public.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), said the trade agency was working with closely with U.S., Chinese Governments on coronavirus response and readiness.
“FDA Commissioner Hahn is exactly right that we must ‘facilitate the development and availability of investigational medical products’ to address this global threat," Whitaker said in a release. "We are working with key U.S. government agencies – including HHS, FDA, and CDC – as well as the Chinese government, to identify how we as an industry can help ensure that providers and patients everywhere have access to the medical technologies they need to help diagnose and fight this deadly virus.”
A coronavirus is a kind of common virus that causes an infection in the nose, sinuses, or upper throat. Most are not deadly. The World Health Organization identified this new type of coronavirus earlier this month, which originated in China.
There are more than 4,000 cases of the virus that have been confirmed in China. So far there are more than 100 people that have succumbed from the disease – however, none of those deaths were in the U.S. There are five reported cases in the U.S. and the coronavirus has now spread to Germany.