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911 articles found
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Coronavirus (COVID-19) Update: November 12, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On November 9, 2021, the FDA posted an updated Molecular and A... -
FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance MachinesToday, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bile...
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Coronavirus (COVID-19) Update: November 5, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, Friday, November 5, 2021, the FDA authorized another ov...
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FDA In Brief: FDA Provides New Draft Guidance on Premarket Submissions for Device Software FunctionsThe following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health “As technology continues to advance...
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Coronavirus (COVID-19) Update: November 2, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Friday, October 22, the FDA announced that it found two lot...
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Coronavirus (COVID-19) Update: October 29, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Friday, October 22, 2021, Acting FDA Commissioner Janet Woo...
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FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of AgeToday, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The auth...
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FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseasesThe U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for t...
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FDA Strengthens Safety Requirements and Updates Study Results for Breast ImplantsToday, the U.S. Food and Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.First,...
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FDA In Brief: FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning PracticeThe following quote is attributed to Bakul Patel, director of the FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health “With artificial intelligence a...