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256 articles found
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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... -
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... -
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... -
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... -
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... -
FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National InterestsThe U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug... -
FDA Launches Agency-Wide AI Tool to Optimize Performance for the American PeopleThe U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficien... -
FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing FirmsThe U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering da... -
FDA and CBP Seize Nearly $34 Million Worth of Illegal E-Cigarettes During Joint OperationThe U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. Th... -
FDA takes steps to enhance state importation programs to help lower prescription drug pricesThe U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to...