Regulatory response: FDA authorizes emergency 2019-nCoV diagnostic, EMA activates emergency plan

FDA and EMA each unveiled measures Tuesday to combat the 2019-nCoV outbreak, with the U.S. agency issuing emergency use authorization for a diagnostic and its European counterpart activating its emerging health threats management plan.

Both come the week after WHO declared the coronavirus infection a Public Health Emergency of International Concern and HHS deemed it a public health emergency (see “U.S. Declares 2019-nCoV a Public Health Emergency” and “WHO Declares Coronavirus Public Health Emergency”)...