OBJECTIVES: Patient-reported outcomes (PROs) are increasingly important in drug development, HTA and patient care. FDA guidance on PROs was issued in 2009 and PROs were included in the FDA January 2016 Pilot Clinical Outcome Assessment (COA) Compendium. The objective of this analysis was to characterize the PROs in the Compendium to add to our understanding of which PROs are more likely to achieve regulatory acceptance. METHODS: The Compendium reports outcomes by FDA review division from COA Qualification Program submissions and approved NME labeling from 2003 to 2014; including outcome of interest, outcome assessment(s) and assessment type [PRO, observer-reported (ORO), clinician-reported (CRO), and performance (PO)]. The Compendium was reviewed to characterize PROs in the context of all outcomes within the review division and in aggregate. Frequency of outcome assessment type was determined. PRO outcome assessment tools were identified and characterized by “level” (e.g. generic, disease specific), type of data and collection method. RESULTS:   Approximately 1/4 of Compendium outcomes had COA submissions, implying the majority of outcomes were from label claims. Outcome assessments were most frequently PROs (48%) or CROs (39%); POs (11%) and OROs (3%) were infrequent. All OROs were parent observations in pediatric studies. The number of PRO assessments was greatest in Pulmonary, Allergy & Rheumatology (22) and Gastroenterology & Inborn Error (21). As a percent of total outcome assessments, PROs were least frequent in Dermatology & Dental (13%) and Psychiatry (10%). Most PRO assessments measured signs and symptoms of disease. Pain and less frequently fatigue were measured in multiple disease states. Patient satisfaction with treatment was reported once, as was the SF-36. CONCLUSIONS:   Within the FDA Pilot Clinical Outcome Assessment Compendium, patient-reported outcome assessments were frequent; however they were generally disease specific. A health-related quality of life instrument that could be used to compare outcomes across disease states was only listed once.