US FDA Mulling Core Criteria For Patient-Reported Outcomes
Executive SummaryAgency wants public comment on creating clinical outcome assessments that could be adaptable to multiple trials.
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The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.
US FDA Targets Migraine, Schizophrenia And Opioid Sparing Drugs For Clinical Outcome Assessment Development
At public workshop, FDA says it will be flexible on clinical outcome assessments but stakeholders want agency to specify no-no's; digital health technology is appropriate to get more accurate endpoints, agency says.