The US FDA adopted the advice of patient advocates in developing draft guidance on how to submit proposed guidances relating to patient experience data. The document lists other ways that external groups can help advance patient-focused drug development, such as by developing a patient registry, conducting natural history studies or collaborating with sponsors.
Patient Experience Data: US FDA Guidance Offers Other Ways To Share
Beyond submitting proposed guidances to FDA, stakeholders may develop patient registries, conduct natural history studies, and establish partnerships to help advance patient-focused drug development, agency suggests.
