FDA posts Draft Guidance on Innovation Meetings

The FDA has recently posted a Draft Guidance on the procedure for requesting and presenting at a meeting with the Center for Drug Evaluation and Research (CDER). One of the potential topics pharmaceutical companies may want to address at a meeting with CDER concerns development of clinical outcome assessments in the early parts of clinical development prior to a new COA being ready for formal qualification. Vector Psychometric Group has experience presenting the benefits of modern psychometric techniques to the FDA.

From the Guidance:

73 “Clinical outcome assessments in the early phase of development and not yet ready
74 for the Clinical Outcome Assessment Qualification Program: Clinical outcome
75 assessments (COAs) include patient-reported outcomes, clinician-reported outcomes,
76 observer-reported outcomes, and performance outcomes. The CPIM can be a venue for a
77 discussion of the potential approaches to developing COAs to provide evidence of
78 treatment benefit to support marketing approval and labeling claims. The discussion can
79 help requesters understand the needs and goals for COA qualification and answer
80 questions they may have related to the development or selection of COAs in preparation
81 for the qualification process.”