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911 articles found
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FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in DogsToday, the U.S. Food and Drug Administration conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs. This is the first tre... -
FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal DeviceToday, the U.S. Food and Drug Administration authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The device is designed for patients who have an I...
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FDA Approves First Injectable Treatment for HIV Pre-Exposure PreventionToday, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds...
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Coronavirus (COVID-19) Update: December 17, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 15, 2021, the FDA approved an abbreviated new...
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When Would I Use ISO8601 Interval Format?In SDTMIG v3.4 and SDTM v2.0, formats for Date/Time variables are now specified as "ISO 8601 datetime or interval." You may ask “What's that interval format and when would I use it?”Most implementers...
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Variable Metadata Has Changed in SDTM v2.0. How Does This Affect SDTMIG v3.4?SDTM v2.0 is the first major release since the model's original publication in 2004. Among many modifications and updates, the most significant change is that variable metadata is represented in a ne...
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What Do We Mean When We Say Provisional?CDISC employs a rigorous approach to developing data standards. Each standard is informed and shaped by experts, making them not just of the highest quality, but also attuned to the practicalities of...
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SDTM and CDASH: Why You Need BothCDASH and SDTM are each optimized for different purposes, and the philosophy behind each drives the design. SDTM represents cleaned, final CRF data organized in a predictable format that facilitate...
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Are These Findings Just Repeats or Were They Scheduled at Time Points?The SDTMIG’s description of time point variables covers two different use cases: 1. A planned set of findings scheduled relative to a reference time point, usually a dose of study treatment. This is...
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Assessing CausalityThis diagram illustrates the steps that go into assessing the causality of an adverse event. For certain kinds of adverse events, some steps are almost automatic (e.g., an infectious disease can't ha...