On October 23, 2025, FDA released its final guidance regarding Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The guidance is the third guidance in a four-part series of FDA guidance focused on patient-focused drug development (PFDD) that describe how stakeholders, such as patients, caregivers, researchers, medical product developers and others can submit patient experience data and other relevant information that can be used for medical product development and regulatory decision making.