Therapy Areas: Devices
US FDA provides update on COVID-19 situation
5 August 2020 -

Public health agency the US Food and Drug Administration (FDA) said on Tuesday that it has currently authorised 203 tests under EUAs, including 166 molecular tests, 35 antibody tests and two antigen tests to date in the ongoing response to the COVID-19 pandemic.

The agency added that it has updated its COVID-19 Drug Shortages Response webpage to provide information regarding in-use time for certain drugs during the COVID-19 public health emergency.

To protect consumers, the agency has also issued a warning letter jointly with the Federal Trade Commission to MMSTabs.com for selling unapproved and unauthorized products to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

In addition, the agency has issued Emergency Use Authorizations (EUAs) for COVID devices and tests to Abiomed Inc, Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute, Poplar Healthcare, Wren Laboratories LLC as well as Ethos Laboratories.

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