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911 articles found
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FDA Roundup: April 18, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA granted marketing authorization to the NTX100 Tonic Motor Activation... -
FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell TransplantationToday, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a su...
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FDA Roundup: April 14, 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 an emergency use authorization (EUA) for the Azure Fastep COVID-1...
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FDA Roundup: April 11, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA authorized for marketing the MISHA Knee System, an implant placed al...
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FDA Roundup: April 7, 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 recall notice about Philips Respironics Recall Certain Reworked...
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FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of MakenaToday, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to...
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FDA Roundup: April 4, 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Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued draft Guidance for Industry #278, Human User Safety in New and Ab...
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FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient SettingsToday, the U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient p...
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Can I add this variable to my SDTMIG dataset?If your data is based on a general observation class, you can determine the answer to this question by consulting the SDTM. Qualifiers for your general observation class, timing variables, and identif...
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Do I have to use the variable labels in the SDTMIG?In all versions of the SDTMIG through v3.2, the "Conformance" section includes the following as a criterion for conformance: Using SDTM-specified variable labels for all standard domains The SDS tea...