Regulatory Science Framework

 

The goal of this framework is to harness regulatory science research to accomplish the following three charges that directly align with FDA’s mission, to:

Focus Areas for Charge I

1. Alternative Methods
2. Advanced Manufacturing Approaches
3. Analytical and Computational Methods
4. Biomarkers
5. Clinical Outcome Assessment
6. Complex and Novel Clinical Trial Design
7. Predictive Toxicology
8. Methods for Assessing Behavioral, Economic, or Human Factors
9. Approaches to Incorporate Patient and Consumer Input
10. Methods to Assess Real-World Data to serve as Real-World Evidence
11. Methods to Assess Data Source Interoperability

Focus Areas for Charge II

1. Methods to Assess Real-World Data to Support Regulatory Decision-Making
2. Using and Validating Artificial Intelligence Approaches
3. Novel Clinical Trial Design, Statistical and Epidemiologic Methods
4. Automated Reporting Tools for Adverse Events and Active Surveillance
5. Methods to Improve Communication About Risk to Patients and Consumers
6. Approach to Expand Data Capacity, and Increase Data Quality and Usen
7. Efforts to Harmonize Existing and Emerging Data Standards

Focus Areas for Charge III

1. Reinforce Medical countermeasures Initiative (MCMi)
2. Antimicrobial Resistance
3. Patient and Consumer Engagement
4. Substance Use and Misuse
5. One Health Approaches
6. Global Product Safety net

These three charges are foundational to FDA’s mission, and thus are not expected to change. We have designated areas to target regulatory science efforts that support the FDA’s mission for each charge. The areas of regulatory science are designed to change with the evolution of science, technologies, and public health needs.