US FDA Expands Patient Input To New Area: Orphan Grant Applications
Patient experience will be incorporated into agency orphan grant reviews, and outside rare disease experts will help make decisions.
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OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.
US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
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.