> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Clinical Outcome Assessments
- URL: https://www.fdaweb.com/draft-guide-on-clinical-outcome-assessments/
- Published: 2022-06-30T12:00:00.000Z
- Updated: 2026-09-14T17:50:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152207

*Federal Register* notice: FDA is making available a draft guidance entitled ‘‘Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” The document describes how stakeholders such as patients, caregivers, researchers, medical product developers and others, can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-06-30/pdf/2022-13952.pdf?ref=fdaweb.com).