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276 articles found
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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... -
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...
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Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home TestToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid ampl...
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FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for SaleThe U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermograph...