Existing Wording: The United States Food and Drug Administration (FDA) defines PROs as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. The outcome can be measured in absolute terms (e.g., severity of a symptom, sign, or state of a disease) or as a change from a previous measure".

Comment:

Recommend adding the reference to the FDA guidance on ePRO "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims"

Summary:

Add FDA Guidance on PROs