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# Workshop on Patient Experience Data in Drug Development
- URL: https://www.fdaweb.com/workshop-on-patient-experience-data-in-drug-development/
- Published: 2025-08-18T12:00:00.000Z
- Updated: 2026-09-14T15:19:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159704

FDA is announcing a two-day (9/18-19) virtual public workshop to address methodological challenges in collecting and using patient experience data to inform drug development and regulatory decision-making. The “Patient-Focused Drug Development: Workshop #2” is the second in a series mandated by the user fee program and intended to discuss how patient and caregiver perspectives can be more systematically incorporated into benefit-risk assessments, product labeling, and clinical outcome assessments, according to an [agency notice](https://www.fda.gov/drugs/news-events-human-drugs/patient-focused-drug-development-workshop-2-discuss-methodologic-and-other-challenges-related?ref=fdaweb.com). 

Topics will include best practices for gathering reliable patient experience data, evaluating submissions, and overcoming methodological hurdles. The agency will also present a draft version of an updated “evidence dossier template,” designed to help sponsors more effectively submit patient experience evidence in support of clinical outcome measures.