Regulates drugs, devices, and biologics in the United States. Operates the Clinical Outcome Assessment (COA) Qualification Program and Drug Development Tool (DDT) program.
Visit FDAGold-standard dementia staging instrument.
CDR-SB used as a primary or co-primary outcome in early Alzheimer's disease trials
FDA guidance: Early Alzheimer's DiseaseStandard MS disability staging scale.
Primary disability outcome in multiple sclerosis trials supporting MS drug approvals
FDA Multiple Sclerosis drug approval reviewsClinician-rated depression severity, the historical trial standard.
Primary efficacy endpoint in major depressive disorder trials
FDA antidepressant drug approval reviewsAD trials cognitive endpoint (11- and 13-item forms).
Primary cognitive endpoint for mild-to-moderate Alzheimer's disease registration trials
FDA guidance: Early Alzheimer's Disease: Developing Drugs for TreatmentBrief self-report for GAD severity.
Anxiety severity measurement supporting drug development programs
FDA PRO GuidanceGold-standard nine-item depression severity self-report.
Depression screening and severity measurement in clinical trials and labeling
FDA PRO GuidanceStandardized parent interview pairing with ADOS-2 for ASD diagnosis.
Diagnostic reference for ASD trial eligibility
FDA autism workshopsCore oncology QOL questionnaire, basis of the FACIT family.
HRQoL endpoint in oncology label claims
FDA guidance: Patient-Reported Outcome Measures: Use in Medical Product DevelopmentGold-standard semi-structured observation for ASD diagnosis across the lifespan.
Diagnostic reference instrument cited in autism drug development discussions
FDA workshops on autism drug developmentMDS-revised Parkinson's rating scale.
Motor and non-motor outcomes in Parkinson's disease drug development
FDA guidance: Parkinson's Disease: Developing Drugs for TreatmentBrief cognitive screen for dementia.
Cognitive screening for trial eligibility in dementia studies
FDA dementia drug development guidanceClassic 21-item self-report measure of depression severity.
Secondary depression severity outcome in trials
FDA PRO Guidance