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Summary

The Food and Drug Administration (FDA) is announcing a virtual public workshop with the National Eye Institute (NEI), entitled, “Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires.” The purpose of the workshop is to highlight the importance of patients’ perspectives, patient-reported outcomes (“PROs”), and questionnaires to measure visual function and vision-related quality of life (“VFQs”) in vision research and clinical care. The goal is to identify future steps in the development of PROs and VFQs for a variety of ocular conditions and varying degrees of visual impairment.

Background

The workshop aims to:

• Highlight the importance of patients’ perspectives, PROs, and questionnaires to measure VFQs in vision research and clinical care. 
• Help to identify future steps in developing PROs and VFQs for a variety of ocular conditions and varying degrees of visual impairment.  

The workshop is open to the public, and it is anticipated that researchers from academia, industry, non-profits, other government agencies, patients and care partners will attend. 

• Date and Time
• Webcast
• Prelimiary Agenda
• Registration
• Comments
• Contact

Date and Time

This virtual meeting will be held on September 29, 2023, from 10 a.m. until 4 p.m. ET.

Webcast

The public workshop with live captioning will be webcasted. Please visit Workshop on Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires | National Eye Institute (nih.gov). 

Preliminary Agenda

The preliminary public meeting/workshop agenda is available at, Workshop on Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires | National Eye Institute (nih.gov). More information will be made available as presenters and topics are confirmed.

Registration

If you wish to attend this workshop, you must register at Virtual Event Registration. There is no fee to register for the public. 

For special accommodations due to a disability, or need additional information regarding registration, please contact Workshop on Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires | National Eye Institute (nih.gov).

Comments

The Docket will open for public commenting on September 29, 2023. The Comments regarding the workshop should be submitted to the docket FDA-2023-N-3787 by October 30, 2023. 

Please refer to the Instructions for Submitting Comments available in the Docket to ensure that your feedback is received.  

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Contact

For questions regarding workshop content, please contact:

Tieuvi Nguyen
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Ave.
Silver Spring, MD 20993 
301-796-7018
Tieuvi.Nguyen@fda.hhs.gov