Posted by Michael Wonder on 17 Mar 2020
FDA provides more regulatory relief during outbreak, continues to help expedite availability of diagnostics
16 March 2020 - Today, as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on 29 February on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S.
We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.
