2026 Public Comment | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products View PDF
2026 Public Comment | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing Read more
2026 Peer Review | Early Circulating Tumor DNA Dynamics Predict Overall Survival in Solid Tumors: A Landscape Assessment Read more
2026 Peer Review | A Cross-National Review of Novel Oncology Approvals in the United States and China (2020–2025) Read more
2026 Peer Review | Associations between early changes in circulating tumor DNA (ctDNA) and outcomes across randomized trials: Insights from the ctMoniTR project Read more
2026 Peer Review | Assessing contribution of effect in oncology combination therapies: lessons learned to inform and optimize future registrational trial designs Read more
2026 White Paper | Modernizing The FDA Biomarker Qualification Program Strengthening Regulatory Clarity And Broadening Biomarker Use In Drug Development View PDF
