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105 articles found
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Coronavirus (COVID-19) Update: March 16, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On March 15, 2021, the FDA launched the COVID-19 EUA FDA Adver... -
Coronavirus (COVID-19) Update: March 5, 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 sent letters to 25 firms that produce and issue “FDA r...
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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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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: 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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Coronavirus (COVID-19) Update: February 12, 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, the FDA posted the webpage, COVID-19 Vaccine Safety...
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Coronavirus (COVID-19) Update: February 5, 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 scheduled a meeting of its Vaccines and Related Bi...