On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop will feature presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present. In addition, this workshop will present a draft version of an updated evidence dossier template to facilitate the submission of evidence to FDA to support a Clinical Outcome Assessment.

Workshop Materials:

This webpage will be updated as meeting materials are developed.

Background:

Under the seventh iteration of the Prescription Drug User Fee Act, incorporated as part of the FDA User Fee Reauthorization Act of 2022, FDA committed to facilitate the advancement and use of systematic approaches to collect and utilize robust and meaningful patient and caregiver input that can more consistently inform drug development and, as appropriate, regulatory decision making. This included issuing a Request for Information (RFI) available at https://www.federalregister.gov/documents/2023/05/02/2023-09265/methodological-challenges-related-to-patient-experience-data-request-for-information-and-comments to elicit public input on methodologic challenges related to patient experience data, and other areas of greatest interest or concern to public stakeholders. The RFI was published on May 2, 2023, and the public comment period was open until July 3, 2023. A summary of the comments was published on December 12, 2023, and is available at https://www.regulations.gov by entering the following docket number: FDA-2023-N-1506. The input received in response to the RFI helped inform the topics for the first public workshop in this series, Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data, held on December 13, 2024. The discussions from the first workshop helped to inform the topics for this second workshop. These workshops, together with the input received in response to the RFI, will help FDA identify priorities for future work.

Additional information will be posted as it becomes available.

Registration: To register for this virtual workshop, visit: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data