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911 articles found
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Coronavirus (COVID-19) Update: June 25, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:Today, the FDA is announcing revisions to the patient and provider fact sheets for... -
Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of...
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FDA In Brief: FDA Encourages Inclusion of Patients with Incurable Cancers in Oncology Clinical Trials Regardless of Prior TherapiesThe following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Dr...
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Coronavirus (COVID-19) Update: June 22, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms...
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FDA Approves First Oral Blood Thinning Medication for ChildrenToday, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where bl...
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FDA Approves a Nasal Antihistamine for Nonprescription UseThe U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (...
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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FDA In Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical DevicesThe following quote is attributed to William Maisel,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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FDA Approves StrataGraft for the Treatment of Adults with Thermal BurnsToday, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgic...