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276 articles found
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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... -
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...
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COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food PackagingAfter more than a year since the coronavirus disease 2019 (COVID-19) outbreak was declared a global health emergency, the U.S. Department of Agriculture, the U.S. Food and Drug Administration and the...
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Coronavirus (COVID-19) Update: February 16, 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...