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911 articles found
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FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a DecadeToday, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade.“Computed tomography is an important medical... -
FDA In Brief: FDA Warns Consumers of Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WANDThe following quote is attributed to Thalia Mills, Ph.D., director, Division of Radiological Health, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiolo...
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FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of SunscreensThe U.S. Food and Drug Administration today took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter...
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FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain PopulationsToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at lea...
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FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for AnimalsToday, the U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues, and cell- and tissue-based prod...
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FDA In Brief: FDA Publishes Material Safety Data to Promote Safer, More Effective Medical DevicesThe following quote is attributed to Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories in the FDA’s Center for Devices and Radiological Health. “As part...
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FDA Authorizes Software that Can Help Identify Prostate CancerToday, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for...
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FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter DrugsThe following quote is attributed to Theresa M. Michele, M.D., director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research “Over-the-counter (OTC) d...
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Coronavirus (COVID-19) Update: September 17, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Sept. 17, the FDA issued a Letter to Health Care Providers...
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FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye ConditionsThe U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, in...