Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data September 18 - 19, 2025

https://www.fda.gov/drugs/news-events-human-drugs/patient-focused-drug-development-workshop-2-discuss-methodologic-and-other-challenges-related?utm_medium=email&utm_source=govdelivery Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data Day 1: Tue, Sept. 18, 2025; 12:30 p.m. - 5 p.m. ET Day 2: Wed, Sept. 19, 2025; 12:30 p.m. - 4 p.m. ET On September 18 and 19, 2025, the 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. https://fda.zoomgov.com/webinar/register/WN_8FiAJfirS3W2WpC_8K0Zww?utm_medium=email&utm_source=govdelivery#/registration