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256 articles found
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FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or RepairToday, the U.S. Food and Drug Administration issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or rep... -
EPA, FDA, and USDA Issue Joint Regulatory Plan for BiotechnologyIn response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protec...
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FDA Roundup: May 7, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee...
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FDA Roundup: May 3, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced the availability of draft guidance for industry (GFI) #290 (VI...
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FDA Roundup: April 30, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development o...
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FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed TestsToday, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health ca...
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FDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory CommitteesToday, the U.S. Food and Drug Administration announced it will host a listening session in June as part of its broader work to optimize the use of, and processes for, advisory committees. This virtual...
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FDA Roundup: April 26, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development o...
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FDA Approves New Treatment for Uncomplicated Urinary Tract InfectionsToday, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates...
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FDA Roundup: April 23, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a new initiative aimed to help reimagine the home environment...