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FDA s End-of-Year Gifts: COVID-19 Diagnostic Tests and Collection Devices for Home Use | Morgan Lewis

To embed, copy and paste the code into your website or blog: The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. These newly authorized testing options are expected to help address the critical public health need for additional COVID-19 test capacity. FDA’s authorization of these new EUAs also makes good on promises the Agency made to prioritize its review of rapid and at-home test solutions.

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