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911 articles found
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FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and WisconsinThe U.S. Food and Drug Administration today announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency. These Mutual Reliance agreemen... -
FDA In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied AuthorizationsThe following quote is attributed to Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products: “The FDA is responsible for ensuring that new tobacco products are put through the a...
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FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded DrugsCompounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to help preserve access to compounded drugs for p...
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Coronavirus (COVID-19) Update: October 5, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, on Sept. 28,...
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Coronavirus (COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for ConsumersToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which a...
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FDA Finalizes Two Foundational Rules for Companies Seeking to Market New Tobacco ProductsToday, the U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for th...
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Federal officials seize spices and food additive products held under insanitary conditions from a Florida warehouseThe U.S. Food and Drug Administration today announced that, on behalf of the agency, the U.S. Marshals Service conducted a mass seizure of FDA-regulated spices and food additive products held for sale...
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Coronavirus (COVID-19) Update: October 1, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Sep. 24, Janet Woodcock, M.D., Acting FDA Commissioner and...
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FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger ChildrenToday, the U.S. Food and Drug Administration is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the cur...
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Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 PandemicA study released today from the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) estimated that more than 2 million U.S. middle and high school students...