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278 articles found
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FDA Roundup: September 13, 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 published the FDA Voices: “Join FDA for the First National Hispa... -
FDA Authorizes First Over-the-Counter Hearing Aid SoftwareToday, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple Air...
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FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab PracticesToday, the U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise...
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FDA Roundup: September 10, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a warning letter issued to Root Bioscience Brands LLC, doing bu...
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Youth E-Cigarette Use Drops to Lowest Level in a DecadeHalf a million fewer U.S. youth reported current use of e-cigarettes in 2024 compared to 2023, according to new data from the National Youth Tobacco Survey (NYTS) released today by the U.S. Food and D...
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FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating VariantsToday, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants t...
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FDA Roundup: August 30, 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 approved a new indication for ACAM2000, to include the preventio...
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FDA Issues Final Rule Increasing the Minimum Age for Certain Restrictions on Tobacco SalesToday, the U.S. Food and Drug Administration announced a final rule that raises the minimum age for certain restrictions on tobacco product sales. These requirements are in line with legislation signe...
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FDA Roundup: August 27, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA revised the Emergency Use Authorization for Pemgarda (pemivibart) t...
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FDA Roundup: August 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 issued a Small Entity Compliance Guide (SECG) to assist small entities...