Table 1 Strategic areas of regulatory sciences research.

Information in the table is from www.fda.gov/downloads/scienceresearch/specialtopics/regulatoryscience/ucm268225.pdf.

Strategic research areaExamples 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