COVID-19: FDA Official Announces 200 EUAs, Clarifies Human Factors Testing Rules
The US FDA’s diagnostics chief also addressed school screening and post-pandemic approval plans during a recent webinar.
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COVID-19: More Virtual Town Halls From FDA Through August
More webinars are on the way from the US agency that are aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
FDA Greenlights Second Pooled Sample COVID-19 Test As Crucial Tool To Reopen US Economy
US regulators have re-issued an EUA to LabCorp’s COVID-19 molecular diagnostic test for pooled sampling. While the method could speed up testing and use less resources, it also can result in false negatives.
Antibody Testing During And After The Pandemic: Not All Tests Are Created Equal
While the main role of SARS-CoV-2 antibody testing is currently limited to determining exposure to the virus in populations, the scientific community is working hard to define the neutralizing properties of the antibodies detected, and the duration of the immune response. As a result, antibody testing could be here to stay for the long term for monitoring populations, testing vaccines and selecting patients for trials of a variety of new therapies to treat numerous conditions.