There's More To Patient Experience Data Submissions Than Just Guidances, Advocates Tell US FDA
Forthcoming 'guidance on guidance,' required under 21st Century Cures Act, should explain different ways that advocacy groups can get patient experience data in front of FDA and provide an opportunity for early interactions before groups go down the guidance development route.
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Promoting innovation, expansion of data use, and patient and consumer empowerment will affect agency work going forward, the FDA Commissioner said in his first all-staff address. Absent from his all-hands memo was drug pricing, opioids, or any other potentially political themes.
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.
Agency wants public comment on creating clinical outcome assessments that could be adaptable to multiple trials.