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138 articles found
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Coronavirus (COVID-19) Update: July 6, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Thursday, June 29, 2021, Acting FDA Commissioner Janet Wood... -
FDA In Brief: FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK SurgeryThe following quote is attributed to William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality, in the FDA’s Center for Devices and Radiological Health “LASIK i...
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FDA In Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical DevicesThe following quote is attributed to William Maisel, M.D., director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health "Many medical devices...
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Coronavirus (COVID-19) Update: June 15, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Following our update on June 11 on the Emergent BioSolutions f...
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Coronavirus (COVID-19) Update: June 11, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On June 10, the FDA issued a safety communication warning the...
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Coronavirus (COVID-19) Update: June 8, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The White House, the U.S. Department of Health and Human Servi...
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Coronavirus (COVID-19) Update: June 4, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On June 1, the FDA approved an abbreviated new drug applicatio...
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Coronavirus (COVID-19) Update: June 1, 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 a safety communication to warn the public to st...
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Coronavirus (COVID-19) Update: May 28, 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, FDA released the Medical Countermeasures Initiative...
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Coronavirus (COVID-19) Update: May 25, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA updated its guidance, Emergency Use Authorizati...