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FDA (CDER)
GUIDANCE FINAL
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
Published: 10/22/2025Detected: 3/20/2026

Summary preview

Clarifies FDA’s expectations for selecting, developing, and modifying fit-for-purpose clinical outcome assessments (COAs) to support patient-focused drug development.

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