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911 articles found
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FDA Roundup: June 23, 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 an updated Consumer Update to remind parents about the dang... -
FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular DystrophyToday, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a co...
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FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco Bars E-CigarettesToday, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both b...
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FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer BiomarkersToday, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians sel...
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FDA Roundup: June 20, 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 its report on the Occurrence of Foodborne Illness Risk Factors...
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FDA Roundup: June 16, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted information on its website regarding the formula for COVID-19 vac...
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FDA Roundup: June 13, 2023Today, 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: “Accelerating Rare disease Cures (ARC) Program...
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FDA Provides Draft Recommendations to Help Reduce Microbial Contamination in Tattoo InksToday, the U.S. Food and Drug Administration issued a draft guidance to help manufacturers and distributors recognize situations that will prevent microbial contamination in tattoo inks.“With about 30...
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FDA Roundup: June 9, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided information to health care providers and facilities on oxygenat...
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FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review ProcessToday, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to...