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911 articles found
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Federal judge enters consent decree against Washington state juice processorThe U.S. District Court for the Eastern District of Washington entered a consent decree between the U.S. Food and Drug Administration (FDA) and Valley Processing, Inc. of Sunnyside, Washington, along... -
FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit Premarket Applications by DeadlineToday, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids...
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FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic EpilepsyToday, the U.S. Food and Drug Administration granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to control seizures in dogs with id...
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CBP, FDA Seize Counterfeit, Unauthorized E-CigarettesU.S. Customs and Border Protection officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration announced today that they have...
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FDA Releases Artificial Intelligence/Machine Learning Action PlanToday, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan descri...
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FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in DogsToday, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia-CA...
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Coronavirus (COVID-19) Update: January 8, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:The FDA alerted clinical laboratory staff and health care providers that genetic v...
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FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory StaffThe U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant...
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Coronavirus (COVID-19) Update: January 5, 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 posted a new webpage on the Coronavirus Aid, Re...
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FDA Statement on Following the Authorized Dosing Schedules for COVID-19 VaccinesTwo different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their sec...