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911 articles found
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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... -
Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home TestToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid ampl...
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FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies, Young ChildrenThe U.S. Food and Drug Administration takes exposure to toxic elements, such as arsenic, mercury, cadmium and lead, in the food supply extremely seriously, especially when it comes to protecting the h...
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FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for SaleThe U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermograph...
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Federal judge enters permanent injunction against New York-based dietary supplement manufacturerA dietary supplement manufacturer and two of its executives have been ordered by a federal court to stop manufacturing, holding, or distributing any articles of food, including dietary supplements, un...
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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 Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal HysterectomyThe U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in c...
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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...