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 View PDF
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
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 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 Public Comment | Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Read more
2025 Public Comment | Request for Information on the Development of an Artificial Intelligence (AI) Action Plan Ensuring Efficient and Innovative Regulatory Approaches for AI in Drug Development View PDF
2024 Public Comment | Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry Read more
2024 Public Comment | Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry Read more
