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911 articles found
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Why "study subject" Instead of "study participant"? -
HHS, FDA Praise Consumer Brands Association’s Vow to Remove Artificial Colors from America’s Food SupplyWASHINGTON – Today the leadership of the U.S. Department of Health and Human Services (HHS) praised the Consumer Brands Association for its pledge on behalf of the makers of the nation’s food and beve...
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Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and ResearchThe U.S. Food and Drug Administration today announced the appointment of George Francis Tidmarsh, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER). In this role, Dr. Tidm...
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FDA to Revoke 52 Obsolete Standards of Identity for Food ProductsThe U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned frui...
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FDA Issues Warning Letters to Firms Marketing Products Containing 7-HydroxymitragynineThe U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action...
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FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels...
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A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common SenseAs I mark my hundredth day on the job at the FDA, I’m proud to celebrate the agency’s accomplishments in the bipartisan effort to Make America Healthy Again. I came here with big questions: Why does i...
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FDA Embraces Radical Transparency by Publishing Complete Response LettersThe U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the...
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FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and ChildrenThe U.S. Food and Drug Administration today called for increased attention to product recall communications from industry leaders involved in the manufacturing and distribution of infant formula, baby...
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FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell ImmunotherapiesThe U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric ant...