US FDA Mulling Core Criteria For Patient-Reported Outcomes
Agency wants public comment on creating clinical outcome assessments that could be adaptable to multiple trials.
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US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.
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
Grant solicitation, a different approach than agency has so far taken with biomarkers, signals growing importance of patient input in drug development.