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22 articles found
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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... -
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is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued the revised, draft guidance Formal Meetings Between the FDA...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and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance “Labeling for Biosimilar and Interchangeable B...
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FDA Issues Warning Letters to Firms Marketing Unapproved Eye ProductsThe U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letter...
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FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating VariantsToday, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to p...
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FDA Roundup: September 1, 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 cleared for marketing the updated 23andMe Personal Genome Service...
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FDA Issues Warning Letters to Three Infant Formula ManufacturersToday, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that...
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FDA Roundup: August 29, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA informed consumers in Treating and Dealing with ADHD about FDA-appro...