Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments October 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome?utm_medium=email&utm_source=govdelivery FDA Issues Final Guidance on Patient-Focused Drug Development The U.S. Food and Drug Administration issued a final guidance “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders.” This guidance (Guidance 3) is the third in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. The purpose of this guidance is to help sponsors identify or develop fit-for-purpose Clinical Outcome Assessment measures of patients’ health that are appropriate for use in a medical product development program.