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  1. Advancing Regulatory Science

Regulatory Science Framework

 

FDA Mission Protect and Advance Public Health Three Pillars of 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

  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

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

  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

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

  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
  7. Emerging Technologies

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.

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