Public Comment | Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product
Public Comment | Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Guidance for Industry
Public Comment | Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development Guidance for Industry
Public Comment | FDA CBER OTP Public Listening Meeting – Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies
Public Comment | Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects
Friends of Cancer Research Response to National Cancer Institute’s Request for Information: Benchmarks for Artificial Intelligence in Cancer Research and Care
Public Comment | FDA’s Considerations for Generating Clinical Evidence from MRCTs
Public Comment | Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
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
The integration of Artificial Intelligence (AI) and Machine Learning (ML) into drug development and diagnostics presents unprecedented opportunities to enhance patient care, streamline drug discovery, and improve the accuracy of diagnosis and treatment selection. However, these technologies may require a new regulatory paradigm, particularly given their adaptive nature. To ensure safety, efficacy, and reliability, regulatory…