2025 Public Comment | Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Read more
2025 Public Comment | Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Ensuring Efficient and Innovative Regulatory Approaches for AI in Drug Development View PDF
2025 Discussion Document | Considerations For Developing Reference Data Sets For Digital Pathology Biomarkers View PDF
2025 White Paper | Innovative Validation And Regulatory Processes For Companion Diagnostic Tests For Rare Biomarkers Or Indications View PDF
2024 Public Comment | Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry Read more
2024 Public Comment | Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry Read more
2024 Poster | SABCS 2024 | Agreement Across 10 Artificial Intelligence Models in Assessing HER2 in Breast Cancer Whole Slide Images: Findings from the Friends of Cancer Research Digital PATH Project View PDF
2024 Poster | SITC 2024 | The Impact of Treatment Modalities on Use of ctDNA as an Early Endpoint in aNSCLC Trials View PDF
2024 White Paper | Framework for Integrating Change in ctDNA Levels in Advanced Cancer Clinical Trials to Support Meta-analyses for Intermediate Endpoint Validation View PDF
