FDA to allow states to authorize coronavirus tests

Pablo Tucker
March 19, 2020

During the COVID-19 outbreak, FDA has exercised its emergency use powers to expedite development of, and access to, diagnostic tests. The change will also cut down the turnaround time between getting tested and getting results back because labs have the authority to confirm positive coronavirus cases on their own now.

Moreover, the FDA has updated a policy on diagnostic testing for coronavirus (COVID-19) that was originally issued on 29 February 2020 in order to achieve more quick testing capacity in the United States. Now, as a result of the change announced last night by the FDA, the Company's test kit will soon be available for use by and marketed to a wide array of USA laboratories, without first requiring Emergency Use Authorization. The labs do not have to engage with the FDA nor will they need to apply for Emergency Use Authorization (EUA). The agency believes that a 15-period should be sufficient to prepare an EUA filing. Due to the limited number of COVID-19 tests that exist in the US right now, not everyone can be tested but if you present with symptoms or have been in contact with a person who has the virus, then you need to be tested.

Finally, our updated policy provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. The agency said that while serological tests are less complex than molecular tests and only identify antibodies, it does not intend to object to vendors developing these tests for SARS-CoV-2 infection.

FDA is doing a commendable job by continually maintaining 24/7 operations and also by providing support to test developers and laboratories as they are into distribution of tests across the country during the time of urgent requirement which has come after the coronavirus outbreak. "The FDA is actively reviewing and discussing the application as we speak". We don't continuously use this trope in medication, however I will be able to suppose of not anything higher to explain what has been happening in the USA with the coronavirus outbreak.

"If they fully appreciated the speed at which this would become an urgent clinical concern, they might have picked a different strategy from the beginning", said Dr. Joshua Sharfstein, a former FDA official who is now a vice dean at Johns Hopkins University.

The Food and Drug Administration is a regulatory agency within the U.S. Health and Human Services Department that is engaged in protecting the public health and well-being by ensuring the safety, effectiveness, as well as security of both human and veterinary medications, vaccines and other biological formulations for use in human and medical devices.

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