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256 articles found
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FDA Roundup: April 19, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA posted a safety communication to inform the public and healthcare... -
FDA Roundup: April 16, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA’s Center for Devices and Radiological Health (CDRH) announced the unveil...
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FDA Roundup: April 12, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA will reopen the comment period for 60 days for the draft guidance “Recom...
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Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy MachinesToday, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America LLC (“Philips Respironics”), Respironics Calif...
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FDA Roundup: April 9, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA authorized for marketing MMI North America, Inc.’s Symani Surgical S...
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FDA Roundup: April 5, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFa...
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FDA Approves New Antibiotic for Three Different UsesToday, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (...
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FDA Roundup: April 2, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA is releasing several scientific review policy memoranda that provide a s...
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FDA Roundup: March 29, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA made several updates to the Mammography Quality Standards Act and...
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FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health EffectsThe U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or afte...