FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.

These guidances are part of FDA’s PFDD efforts in accordance with the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I.

This webpage contains information and documents related to FDA’s development of the methodological PFDD guidances, including public workshops, draft guidances, and hypothetical scenarios, which are all intended to serve as a basis for dialogue. To supplement the PFDD Guidance Series, FDA issued two technical specifications guidance documents, Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theoryexternal link, opens in a new tab and Submitting Patient-Reported Outcome Data in Cancer Clinical Trialsexternal link, opens in a new tab.