GUIDANCE DOCUMENT
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making April 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2023-D-0026
- Docket Number:
- FDA-2023-D-0026
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
This guidance (Guidance 4) is the fourth in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers, researchers, medical product developers, and others) 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.