Comment from Clinical Outcomes Solutions
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Summary: Clinical Outcomes Solutions (COS) supports the use of Patient Focused Drug Development (PFDD) meetings but argues that the FDA should improve how findings from these meetings are translated into regulatory-grade qualitative evidence. They propose specific steps to standardize data collection, analysis, and reporting to better support clinical development programs.
Clinical Outcomes Solutions (COS) thanks FDA for the opportunity to provide feedback on the impacts of Patient Focused Drug Development meetings. Our comments and recommendations are attached.