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911 articles found
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Guideline on When to Use AP-QRS Domains vs. QRS Domains for QRS Instruments Related to Associated PersonsGuideline on When to Use AP-QRS Domains vs. QRS Domains for QRS Instruments Related to Associated Persons -
FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant FormulaThe U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase ad...
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FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application ReviewsThe U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of me...
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FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study ResultsThe U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma. This brings the total number of...
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FDA Approves Two Oral Therapies to Treat GonorrheaThe U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea.The FDA today approved Nuzolvence (zoliflodacin) granul...
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FDA Proposes Expanding Sunscreen Active Ingredient ListToday, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is prop...
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FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic AnemiaThe U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic ane...
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FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever TickToday, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, a...
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FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal AntibodiesToday, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or r...
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FDA Expands Artificial Intelligence Capabilities with Agentic AI DeploymentThe U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees. Agentic AI capabilities will enable the creation of more complex AI workflows...