2026 Public Comment | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Read more
2026 Public Comment | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing Read more
2026 Public Comment | Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause 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 Read more
2025 Public Comment | Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Guidance for Industry Read more
2025 Public Comment | Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development Guidance for Industry 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 Read more
2025 Public Comment | Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Read more
