OBJECTIVES: To highlight some of the common areas that require particular attention when preparing clinical outcome assessment (COA) dossiers, suitable for FDA regulatory label claims, with a particular focus on clinician-reported outcome (ClinRO) measures.  The FDA has provided guidance for the use of Patient-Reported Outcome (PRO) measures for relevant endpoints in clinical trials to support label claims (FDA, 2009). Although several authors have indicated that the standards used to evaluate PRO’s will apply to all COA’s (Burke, 2011; Gwaltney, 2012), the FDA have not published guidelines on ClinRO measures to support label claims. This is surprising given that the ratio of label claims based on ClinRO's is approximately three ClinRO’s to every PRO measure (Burke, 2010).  METHODS: We conducted a review of the literature to ascertain the general level of use of ClinRO’s and to find examples of widely used ClinRO’s. The available evidence for these ClinRO’s was then assessed by the standards of the PRO guidance, specifically in relation to content and construct validity, reliability and other psychometric properties. RESULTS: The literature review revealed that ClinRO’s are common endpoints in clinical trials. However, it was also apparent from the sample of ClinRO’s reviewed, that they fail to meet the evaluative standards prescribed by the FDA particularly in being “well defined and reliable”. CONCLUSIONS: ClinRO’s used as endpoints in clinical trials to support FDA label claims may lack the required evidence set out in the FDA PRO guidance document. Specifically, many ClinRO’s have been developed by clinicians, and widely accepted by clinical peers, without undergoing psychometric evaluation. If the FDA were to evaluate ClinRO’s to the same standards as PRO’s, the ratio of label claims between ClinRO's and PROs may decrease significantly.