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The FDA has asked Scynexis to hold new clinical studies of an intravenous formulation of its antifungal treatment, SCY-078, until the agency can review available pre-clinical and clinical data. Read More
International guidance on pediatric drug development should include provisions for remote electronic consent, and should clarify the information provided to patients prior to their enrollment in clinical trials, according to the Association of Clinical Research Organizations. Read More
Pediatric clinical trials protocols should be designed with input from stakeholders, according to the Clinical Trials Transformation Initiative on antibacterial drugs. Read More