January 27, 2020

• January 27, 2020

                                                                                                                                 

• January 27, 2020
• “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.gv for further information and templates. Also see: How to Submit a Pre-EUA for In vitro Diagnostics to FDA