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911 articles found
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FDA Roundup: May 05, 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 a safety communication to warn consumers and health care pro... -
Why Would a Standards Development Organization Make Non-standard Variables Available on their Website?When an implementer is working how to represent data for a study, they first consult the SDTMIG and SDTM to find the appropriate standard variable. If no appropriate standard variable is found, the SD...
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FDA Approves First Respiratory Syncytial Virus (RSV) VaccineToday, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower...
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FDA Takes Additional Steps to Advance Decentralized Clinical TrialsToday, the U.S. Food and Drug Administration is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related...
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FDA Roundup: May 2, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published a Conversations with Experts QA that focuses on the importance...
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FDA Conditionally Approves First Drug for Anemia in Cats with Chronic Kidney DiseaseToday, the U.S. Food and Drug Administration conditionally approved Varenzin-CA1 (molidustat oral suspension), the first drug for the control of nonregenerative anemia associated with chronic kidney d...
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Where Does My Lab Data Go in SDTMIG v3.4?The earliest version of the SDTMIG had only one domain for tests on biologic specimens taken from a study subject, the Laboratory Test (LB) domain. SDTMIG v3.4 has 10 domains for specimen-based findin...
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FDA Roundup: April 28, 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 a final guidance for industry titled Smoking Cessation and Relate...
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FDA Roundup: April 21, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA approved the MiniMed 780G System for modifications to the SmartGuard (SG...
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Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 VaccinesToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for...