FDA
- WEBCAST Webinar – Patient Engagement in the Design and Conduct of Medical Device Clinical Studies – Final Guidance – MARCH 22, 2022
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-patient-engagement-design-and-conduct-medical-device-clinical-studies-final-guidance?utm_medium=email&utm_source=govdelivery - GUIDANCE DOCUMENT – Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders – FEBRUARY 2022 – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-methods-identify-what-important-patients
- GUIDANCE DOCUMENT – Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders – JANUARY 2022
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-selecting-developing-modifying-and-adapting-patient-reported-outcome-instruments-use - GUIDANCE DOCUMENT – Core Patient-Reported Outcomes in Cancer Clinical Trials Draft Guidance for Industry – JUNE 2021
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/core-patient-reported-outcomes-cancer-clinical-trials - COA COMPENDIUM – June 2021 – https://www.fda.gov/media/130138/download
- Qualified Clinical Outcome Assessments (COA) – https://www.fda.gov/drugs/clinical-outcome-assessment-coa-qualification-program/qualified-clinical-outcome-assessments-coa
- GUIDANCE DOCUMENT – Patient-Focused Drug Development: Collecting Comprehensive and Representative Input – JUNE 2020
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-collecting-comprehensive-and-representative-input - Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making, December 2019 – https://www.fda.gov/media/
132505/download