RE: FDA & Its Sister Agency the CDC4 Feb 2020 22:57
The FDA outlined its approach to expediting the development and availability of critical medical products to prevent, diagnose and treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak on Jan. 27. The agency remains committed to working with developers, international partners and the U.S. government to help support this public health response. The FDA is dedicated to actively working with other 2019-nCoV diagnostic developers to help accelerate development programs and requests for EUAs, in fact several have already requested and received the EUA template for this outbreak. The FDA, among other steps, is providing its highest level of attention to helping expedite the development and review of a variety of medical products being developed to diagnose, treat and prevent the spread of this outbreak.