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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
Sponsors would like to see clearer recommendations for non-inferiority assessments, demonstrating bioequivalence and targets for statistical analysis, before the European Medicines Agency adopts an international guideline on large clinical trials that span multiple regions. Read More
The National Cancer Institute opened a drug formulary as part of a public-private partnership with six pharmaceutical companies, allowing researchers to test the drugs in clinical and preclinical studies — alone or in combination with different companies’ products. Read More