—UPDATE– February 5, 2020: See FDA Issues Emergency Use Authorization for First Coronavirus Diagnostic Panel —END UPDATE—
As the number of illnesses related to the latest coronavirus continues to rise, federal and international agencies are working to beef up their preparedness and response. This includes facilitating the development of countermeasures that include diagnostics, vaccines and therapeutics, because as of right now, no FDA-approved countermeasures exist.
FDA has stated that it is ready and willing to work with companies that are developing medical countermeasures to help expedite the regulatory process. “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 in an FDA news 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.”
FDA has a page dedicated to the Novel coronavirus (2019-nCov). Companies seeking to develop medical countermeasures should review this page, as it provides specific information about how to move forward with diagnostics, vaccines and therapeutics. Companies can also submit their ideas via the link to the BARDA portal for the 2019 novel coronavirus.