> ## 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.

# Patient Experience Data Stakeholder Comments
- URL: https://www.fdaweb.com/patient-experience-data-stakeholder-comments/
- Published: 2023-12-13T12:00:00.000Z
- Updated: 2026-09-14T14:18:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155991

*Federal Register* notice: FDA is making available a summary of the comments received for the “Methodological Challenges Related to Patient Experience Data; Request for Information and Comments” notice published 5/2\. on May 2, 2023\. The input received is intended to help FDA plan two public workshops focused on methodological challenges and will help it identify priorities for future work.

According to the [summary](https://downloads.regulations.gov/FDA-2023-N-1506-0011/attachment%5F1.pdf?ref=fdaweb.com), stakeholders requested greater clarity in how FDA uses patient experience data in its regulatory decisions. “Commenters noted that sponsors may be less likely to invest in patient experience data if they do not understand how FDA will use the information, particularly when limited resources are available,” it says. Additionally, stakeholders recommended expanding the patient experience data tables that are included as part of FDA’s review documentation to report whether patient experience data were considered in decision-making and why or why not.

To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-13/pdf/2023-27312.pdf?ref=fdaweb.com).