CDER Patient-Focused Drug Development Fecha y hora 18 sept 2025 01:30 p. m. 19 sept 2025 01:30 p. m.

https://fda.zoomgov.com/webinar/register/WN_8FiAJfirS3W2WpC_8K0Zww?utm_medium=email&utm_source=govdelivery#/registration Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data 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. Meeting Logistics and Registration Date: September 18-19, 2025 Day 1: Thu, Sep 18 12:30 PM -- 5:00 PM ET Day 2: Fri, Sep 19 12:30 PM -- 4:00 PM ET Registration: https://fda.zoomgov.com/webinar/register/WN_8FiAJfirS3W2WpC_8K0Zww#/registration 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