The FDA provides update of COVID-19
20 July 2020 -

Public health company The US Food and Drug Administration (FDA) reported on Friday that it has issued warning letters to operators of two websites, and, that market unapproved COVID-19 products.

On 15 July 2020, the agency said it approved an abbreviated new drug application, or generic, for heparin sodium, which is an anti-coagulant to prevent blood clotting. It has recognized the increased demand for certain products during the COVID-19 public health emergency and remains deeply committed to facilitating access to medical products to help address critical needs of the American public.

The FDA has issued Emergency Use Authorizations to Boston Heart Diagnostics for its molecular Boston Heart COVID-19 RT-PCR Test and to to Luminex Corporation for its serology xMAP SARS-CoV-2 Multi-Antigen IgG Assay.

To date, the agency has currently authorized 184 tests under EUAs including 152 molecular tests, 30 antibody tests and two antigen tests.