The 21st Century Cures act requires FDA to make a brief public statement about patient experience data for new drug approvals, highlighting the need for FDA to foster efforts to develop standard analysis methods for the regulatory review of PRO data. PRO data can be used to assess symptomatic toxicities as well as disease symptom improvement or functional benefits related to disease control. This patient-centered data can provide important complementary information to support regulatory decisions about the benefits and risks of newly developed therapies. In this session, we will discuss current thinking regarding new and existing PRO instruments that capture symptoms, physical function and other aspects of health related quality of life to inform the evaluation of the patient experience from a regulatory perspective. We conclude by describing various opportunities to convey PRO data from clinical trials including regulatory requirements for including PRO data in labelling as well as exploring other methods to provide PRO data to the public including published manuscripts.