Information in the table is from www.fda.gov/downloads/scienceresearch/specialtopics/regulatoryscience/ucm268225.pdf.
| Strategic research area | Examples of research |
| Modernize toxicology |
• Develop better preclinical models of human adverse events • Use and develop computational methods for predicting drug toxicities |
| Stimulate innovation in clinical evaluations and personalized medicine |
• Develop a virtual physiological patient • Identify and qualify safety and efficacy biomarkers |
| Support new approaches to improve product manufacturing |
• Enable development of improved manufacturing methods (for example, continuous manufacturing versus batch) • Develop and implement modern analytical methods for evaluating product quality (for example, nuclear magnetic resonance imaging) |
| Ensure FDA readiness to evaluate innovative emerging technologies |
• Develop assessment tools for novel diagnostics and therapies • Enhance readiness for new applications of information technology |
| Harness diverse data through information sciences |
• Enhance information technology infrastructure • Develop simulation models for product life cycles, risk assessment, and other regulatory sciences uses |
| Implement a new prevention-focused food safety system |
• Improve information sharing internally and externally through improved IT systems • Develop methods for rapid detection of pathogens that contaminate foods |
| Facilitate development of medical countermeasures |
• Develop, characterize, and qualify animal models for medical countermeasures • Develop high-throughput methods to detect threat agents |
| Strengthen research in social and behavioral sciences |
• Develop methods for aggregating patient preference information with clinical data • Develop best practices for patient preference elicitation studies |