← FDA GUIDANCE
FDA GUIDANCE · FINALOctober 22, 2025

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

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
Administrative / Procedural, Pediatric Product Development
Issue date
October 22, 2025
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