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:

Modernize development and eveluation of FDA-regulated products

Focus Areas for Charge I

Alternative Methods
Advanced Manufacturing Approaches
Analytical and Computational Methods
Biomarkers
Clinical Outcome Assessment
Complex and Novel Clinical Trial Design
Predictive Toxicology
Methods for Assessing Behavioral, Economic, or Human Factors
Approaches to Incorporate Patient and Consumer Input
Methods to Assess Real-World Data to serve as Real-World Evidence
Methods to Assess Data Source Interoperability

Regulatory Science Framework Charge II. Strengthen post-market surveillance and labeling of FDA-regulated products

Focus Areas for Charge II

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

Regulatory Science Framework Charge III. Invigorate public health preparedness and response of the FDA, patients, & consumers

Focus Areas for Charge III

Reinforce Medical countermeasures Initiative (MCMi)
Antimicrobial Resistance
Patient and Consumer Engagement
Substance Use and Misuse
One Health Approaches
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.