2025 Peer Review | Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation Read more
2025 White Paper | Regulatory and Manufacturing Pathways to Expand Access to Genetically Modified Cell Based Therapies Read more
2025 Peer Review | ctDNA Clearance as an Early Indicator of Improved Clinical Outcomes in Advanced NSCLC Treated with TKI: Findings from an Aggregate Analysis of Eight Clinical Trials Read more
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Comment | Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry Read more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Comment | Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry Read more
