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278 articles found
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FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of EntryThe U.S. Food and Drug Administration today announced its initial review of the effectiveness of the FDA ImportShield Program (FISP), which launched in August 2025 to modernize how the FDA reviews imp... -
FDA Takes Steps to Improve Gluten Ingredient Disclosure in FoodsToday, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first...
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FDA Issues Guidance on Modernizing Statistical Methods for Clinical TrialsThe U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make be...
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FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance InnovationThe U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and...
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FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic ProductsThe U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and poly...
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FDA Grants Two National Priority VouchersThe U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potenti...
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FDA Explores New Contracting Approach to Advance Public Health InnovationThe U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between t...
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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...