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911 articles found
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IS Domain Scope Update for the SDTMIG v3.4: A Development History and the Difficulties of Standardizing Complicated Biological ProcessesSection 1: An expanded scope and new definition for the IS domain in the SDTMIG v3.4 The current Immunogenicity Specimen Assessments (IS) domain in the SDTMIG v3.4 is designed to represent data pe... -
TAUG Examples of SDTM DomainsTherapeutic Area User Guides contain many useful examples, but it can be hard to find a useful example since there are over thirty TAUGs, and many TAUGs include examples that are useful outside a part...
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FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula ProductsToday, the U.S. Food and Drug Administration announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of impo...
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Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, AdjuvantedToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory...
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FDA Warns Four Companies for Selling Tainted Honey-based Products with Hidden Active Drug IngredientsToday, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s l...
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FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and CaregiversThe need to diversify and strengthen the U.S. infant formula supply is more important than ever. The recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, h...
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Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain LimitationsToday, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to e...
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FDA Infant Formula Update: July 6, 2022Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased fle...
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FDA Roundup: July 5, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA, in cooperation with the U.S. Centers for Disease Control and Preventio...
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FDA Roundup: July 1, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a request for nominations for consumer representatives to se...