Science & Research
Strategic Plan for Regulatory Science
Advancing Regulatory Science at FDA: A Strategic Plan (August 2011)
The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities — from pre-market review of efficacy and safety to post-market product surveillance to review of product quality. FDA has developed a strategic plan for regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
Contents: Browse the Strategic Plan for Regulatory Science
- Executive Summary
Vision Statement Science Priority Areas 1. Modernize Toxicology to Enhance Product Safety 2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes 3. Support New Approaches to Improve Product Manufacturing and Quality 4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies 5. Harness Diverse Data through Information Sciences to Improve Health Outcomes 6. Implement a New Prevention-Focused Food Safety System to Protect Public Health 7. Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security 8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products Importance of a Strong Regulatory Science Culture and Infrastructure Conclusion Glossary