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277 articles found
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Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, AdjuvantedToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory... -
Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain LimitationsToday, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to e...
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FDA Roundup: July 5, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA, in cooperation with the U.S. Centers for Disease Control and Preventio...
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FDA Roundup: July 1, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a request for nominations for consumer representatives to se...
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Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster DosesOn Tuesday, the U.S. Food and Drug Administration’s independent experts on the Vaccines and Related Biological Products Advisory Committee met to publicly discuss whether a change to the current vacci...
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FDA Roundup: June 28, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-l...
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FDA Roundup: June 24, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced its recognition of JANAAC as an Accreditation Body Under FSMA...
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FDA Roundup: June 21, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance, Non-Clinical Performance Assessment of Tis...
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FDA Roundup: June 17, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA’s National Center for Toxicological Research (NCTR) announced the...
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Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of AgeToday, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children...