Public Comment | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products | September 8, 2026 Share
Peer Review | A Cross-National Review of Novel Oncology Approvals in the United States and China (2020–2025) | July 20, 2026 Share
Public Comment | Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause | April 27, 2026 Share
Public Comment | Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product | January 23, 2026 Share
White Paper | Assessing Contribution Of Effect (COE) In Oncology Combination Therapies Lessons Learned To Inform And Optimize Future Registrational Trial Designs | October 28, 2025 Share
Public Comment | Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development Guidance for Industry | October 20, 2025 Share
Public Comment | FDA CBER OTP Public Listening Meeting – Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies | September 16, 2025 Share
Public Comment | Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects | September 12, 2025 Share
Public Comment | FDA’s Considerations for Generating Clinical Evidence from MRCTs | July 15, 2025 Share
Peer Review | Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation | May 20, 2025 Share
