Advancing Regulatory Science at FDA: A Strategic Plan (August 2011)
FDA's core responsibility 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.
In 2011, FDA developed a strategic plan for regulatory science in which it identified eight priority areas where new or enhanced engagement in regulatory science research is essential to advancing its regulatory mission.
In 2013, FDA added a ninth strategic priority Strengthening the Global Product Safety Net.
- Browse the Plan
- Printer-Friendly PDF [3.4MB]
- Podcast: Comments on the Strategic Plan for Regulatory Science
- Consumer Update: FDA Modernizing Regulatory Science
- Press release: FDA: Regulatory science plan positions agency to foster innovation through better science
- Blog post: Fostering Innovation Through Better Science
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