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277 articles found
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Coronavirus (COVID-19) Update: May 28, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:This week, FDA released the Medical Countermeasures Initiative... -
Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 i...
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Coronavirus (COVID-19) Update: May 25, 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 updated its guidance, Emergency Use Authorizati...
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Coronavirus (COVID-19) Update: May 21, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:The FDA issued a reminder to health care providers to give clear, step-by-step ins...
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FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely AvailableThe following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research Making COVID-19 vaccines widely available is key to getting...
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Coronavirus (COVID-19) Update: May 18, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On May 17, the FDA provided summary information about the stat...
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Coronavirus (COVID-19) Update: May 14, 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, on April 29,...
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Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against PandemicToday, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by...
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Coronavirus (COVID-19) Update: May 7, 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, on May 6, 20...
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Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of OperationsToday, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemi...