FDA issued list suggests company names removed from test list


The US Food and Drug Administration (FDA) began publically listing the names of the company that has been removed from the antibody test list earlier this month. In its initial policy in March, FDA said it would not object to the development and use of antibody tests by laboratories or commercial manufacturers without FDA review or authorization

FDA Commissioner Stephen Hahn said, "Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests. We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public."