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117 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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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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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...
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Coronavirus (COVID-19) Update: March 30, 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 Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric PatientsToday, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to t...
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Coronavirus (COVID-19) Update: March 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:In a March 22 Consumer Update, the FDA provided an update on s...
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Coronavirus (COVID-19) Update: March 19, 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 16, the FDA posted a new web page on FDA.gov, Screeni...
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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...
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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...