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911 articles found
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Oncology Disease Response (RS) SupplementsCDISC has published the first of a new kind of QRS supplement to the SDTMIG, a supplement for an oncology response criterion, Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The... -
Country CodingThe ISO international standard for country codes is ISO-3166, which provides several representations of names for countries (ISO-3166-1) and their subdivisions (ISO-3166-2):Country and Subdivision nam...
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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...
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FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating VariantsToday, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component th...
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FDA Roundup: August 20, 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 approved Lazcluze (lazertinib) in combination with amivantamab for...
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FDA Marketing Authorization Enables Increased Access to First Step of Syphilis DiagnosisToday, the U.S. Food and Drug Administration granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema...