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911 articles found
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Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of AgeThe U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vacc... -
FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain ManagementToday, the U.S. Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and prev...
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FDA Roundup: February 4, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Feb. 3, the FDA issued a revised draft guidance for industry, “Assessment of Pressor...
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FDA Sodium Reduction Efforts Underscored in USDA’s Transitional Nutrition Standards for School MealsOne of the U.S. Food and Drug Administration’s top priorities is to improve the health of Americans through better nutrition. We are pleased to see the U.S. Department of Agriculture (USDA) Food and N...
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FDA Approves First Generic of RestasisThe U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tea...
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FDA Roundup: February 1, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Jan. 31, the FDA released a new video that provides an overview of the 2021 Food Alle...
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Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 VaccineToday, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the p...
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FDA Roundup: January 28, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:As part of the FDA’s efforts to help ensure Americans have access to compounded medicine...
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FDA Roundup: January 21, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA announced two FY 2022 funding opportunities that could provide up to $800...
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FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All WomenToday, as part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the health of all women, the Center for Devices and Radiological Health (CDRH) is sharing its Heal...