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
2025 Public Comment | Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development Guidance for Industry View PDF
2025 Peer Review | Molecular response cutoffs and ctDNA collection timepoints influence on interpretation of associations between early changes in ctDNA and overall survival in patients treated with anti-PD(L)1 and/or chemotherapy Read more
2025 Public Comment | Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects Read more
2025 Public Comment | FDA CBER OTP Public Listening Meeting – Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies View PDF
2025 Friends of Cancer Research Response to National Cancer Institute’s Request for Information: Benchmarks for Artificial Intelligence in Cancer Research and Care View PDF
2025 Peer Review | Intentional heterogeneity in autologous cell-based gene therapies: strategic considerations for first-in-human trials Read more
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
