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911 articles found
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FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities th... -
Coronavirus (COVID-19) Update: April 13, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As the FDA celebrates National Minority Health Month, we’re wo...
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Joint CDC and FDA Statement on Johnson & Johnson COVID-19 VaccineAs of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and...
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FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon CancerToday, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting...
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Coronavirus (COVID-19) Update: April 9, 2021The U.S. Food and Drug Administration (FDA), today, announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA issued a letter to health care personnel and f...
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FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young ChildrenProtecting one of our most vulnerable populations, babies and young children, is among the U.S. Food and Drug Administration’s highest priorities. Today, we’re announcing a new action plan, Closer to...
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Coronavirus (COVID-19) Update: April 6, 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 issued an Emergency Use Authorization (EUA) to Symbiot...
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FDA Releases Investigation Report Following Fall 2020 Outbreak of E. coli O157:H7 Illnesses Linked to Leafy GreensAs part of our ongoing efforts to combat foodborne illness, today the U.S. Food and Drug Administration published a report on the investigation into the Fall 2020 outbreak of Shiga Toxin-Producing E....
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Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test SystemThe U.S. Food and Drug Administration today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test author...
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Coronavirus (COVID-19) Update: April 2, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Following recent FDA actions to support test development, the...