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FDA Published Patient-Focused Drug Development Guidance Document

May 4, 2023
FDA Published Patient-Focused Drug Development Guidance Document: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making

FDA published the fourth in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.

Download the full guidance document here.