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277 articles found
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Coronavirus (COVID-19) Update: March 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:In a March 22 Consumer Update, the FDA provided an update on s... -
Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 InfectionToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that i...
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Coronavirus (COVID-19) Update: March 19, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On March 16, the FDA posted a new web page on FDA.gov, Screeni...
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FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review ProcessToday, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identificati...
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Coronavirus (COVID-19) Update: March 16, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On March 15, 2021, the FDA launched the COVID-19 EUA FDA Adver...
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Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programsTesting remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who...
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Coronavirus (COVID-19) Update: March 12, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, the agency i...
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Coronavirus (COVID-19) Update: March 9, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Friday, the FDA issued an Emergency Use Authorization (EUA)...
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Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID TestToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation...
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Coronavirus (COVID-19) Update: March 5, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA sent letters to 25 firms that produce and issue “FDA r...