FDA Comments Submission: Patient Focused Drug Development - Draft Guidance #4

July 7, 2023

We submitted comments to the US Food and Drug Administration regarding their draft guidance on Patient-Focused Drug Development (PFDD) and incorporating Clinical Outcome Assessments (COAs) into regulatory decision-making. Our comments addressed the FDA's concerns about implementing Goal Attainment Scaling (GAS) as a personalized endpoint in clinical development, and we shared our approach and tools to standardize GAS in clinical development.

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