2026 White Paper | Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors Read more
2026 Public Comment | Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product View PDF
2026 Peer Review | Agreement Across 10 Artificial Intelligence Models in Assessing Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Whole-Slide Images Read more
2025 Peer Review | Enabling access to genetically modified cell therapies through flexible approaches to manufacturing and cost recovery Read more
2025 White Paper | Seamless Clinical Trial Designs in Rare Cancers Leveraging Operational and Adaptive Strategies to Accelerate Drug Development View PDF
2025 White Paper | Assessing Contribution Of Effect (COE) In Oncology Combination Therapies Lessons Learned To Inform And Optimize Future Registrational Trial Designs View PDF
2025 Peer Review | Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program Read more
2025 Public Comment | Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Guidance for Industry View PDF
