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911 articles found
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FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed TestsToday, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure... -
FDA Roundup: September 29, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA released a video titled “Importing FDA-Regulated Products: Human Foods”...
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FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-CigarettesThe U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand. T...
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FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food AllergensToday, the U.S. Food and Drug Administration announced updated draft guidance designed to help food facilities comply with the requirements for current good manufacturing practices (CGMPs) and prevent...
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FDA Roundup: September 26, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the final guidance Cybersecurity in Medical Devices: Quality Syst...
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FDA Roundup: September 22, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued the revised, draft guidance Formal Meetings Between the FDA...
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FDA Roundup: September 19, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA informed the public in the Prostate Cancer Symptoms, Tests and Treatment...
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FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive AgendaToday, the U.S. Food and Drug Administration announced it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary product...
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FDA Roundup: September 15, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance “Labeling for Biosimilar and Interchangeable B...
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How Do I Represent a Pre-specified Finding?In an events or interventions domain, the variable --PRESP = "Y" can be used to indicate that the value in the topic variable (--TERM or --TRT) was pre-specified. However, --PRESP is not a variable th...