PFDD Workshop to Discuss Methodologic & Other Challenges Related to Patient Experience Data - Part 1

On December 13, 2024, FDA hosted a virtual public workshop to discuss methodological challenges related to patient experience data, 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 explored the different types of patient experience data and how FDA utilizes such data for regulatory decision-making, along with considerations for submitting patient experience data to FDA. In addition, this workshop featured presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present.