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277 articles found
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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... -
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...
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Coronavirus (COVID-19) Update: March 2, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The agency has updated its FDA COVID-19 Response At-A-Glance S...
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Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 TestToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly colle...
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FDA Issues Emergency Use Authorization for Third COVID-19 VaccineToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respirat...
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FDA Statement on Vaccines and Related Biological Products Advisory Committee MeetingFollowing today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly w...
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Coronavirus (COVID-19) Update: February 26, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA held a meeting of the Vaccines and Related Biol...
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Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 VaccineToday, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures comm...
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Coronavirus (COVID-19) Update: February 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Yesterday, the FDA issued guidances for medical product develo...
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Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus VariantsToday, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potent...