US FDA Highlights OTC Market With Template To Boost COVID-19 Test Development
FDA template explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.
You may also be interested in...
Energy and Commerce Chairman Frank Pallone and four subcommittee chairs tell FTC and FDA that the degree to which COVID-19 antibodies protect against infection isn't known, but there's "significant demand for antibody tests among consumers who wish to return to their everyday activities against the advice of public health experts."
A top FDA official said the agency has more than doubled its virology review staff to handle the cascade of EUA applications. He said the agency is prioritizing certain COVID-19 diagnostics during a recent webinar.
US regulators have authorized the first COVID-19 test that lets people take a sample of mucus inside their nose at home to check for the novel coronavirus. The maker of the test, LabCorp, says the test will be available in most states within the next few weeks – but health care workers will be given the tests before the general public.