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105 articles found
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Coronavirus (COVID-19) Update: August 3, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:In mid-July, the FDA held a stakeholder call to discuss COVID-... -
Coronavirus (COVID-19) Update: July 13, 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 is announcing revisions to the vaccine recipien...
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Coronavirus (COVID-19) Update: July 9, 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 has taken creative and flexible approaches to address...
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Joint CDC and FDA Statement on Vaccine BoostersThe United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, includ...
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Coronavirus (COVID-19) Update: June 15, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Following our update on June 11 on the Emergent BioSolutions f...
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Coronavirus (COVID-19) Update: June 8, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The White House, the U.S. Department of Health and Human Servi...
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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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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: 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: 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...