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911 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... -
FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain ReliefThe U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic...
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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...