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+353 851890752Archive for April, 2023
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….
Today, 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…
Today, 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…
Today, 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…
Today, 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…
Today, 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…
Today, 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…
Today, 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…
Today, 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…
Today, 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…
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