What in the drug development process is most important to patients? The new FDA draft guidance on Patient-Focused Drug Development released September 30, 2019, provides quantitative and qualitative methods for sponsors to measure a patient’s experience with respect to disease burden and treatment. FDA invites comments until the end of the year.
Want to dig deeper into patient-focused drug development?
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Assessing Biopharmaceutical Company Experience with Patient-Centric Initiatives
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The Patient's Most Engaging Question: Why?
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Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program
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Want to learn more?
Check out INSIDER ACCESS: Making Clinical Trials Work for Special Populations – our exclusive content for DIA Members. A full-length transcript is also available. Or download DIA's Considerations Guide to Implementing Patient-Centric Initiatives in Healthcare Product Development and DIA's Patient Engagement Study Findings from our Collaboration with the Tufts Center for the Study of Drug Development (CSDD).
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From FDA: FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
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