FDA Guidance on Patient-Reported Outcomes

The FDA Guidance on Patient-Reported Outcomes (PROs) provides best practices for developing and using surveys or questionnaires that patients complete to describe their health, symptoms, or quality of life. Its goal is to ensure these tools are reliable, valid, and meaningful, helping healthcare providers and regulators better understand how treatments impact patients directly. By following these guidelines, companies can demonstrate that their medicines or devices genuinely improve patients' well-being based on their own experiences, which supports more informed decision-making in healthcare.