Moving Regulatory Science into the 21st Century
Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.
FDA's Advancing Regulatory Science Initiative builds on the achievements of existing Agency programs, like the Critical Path Initiative's groundbreaking efforts to transform the way medical products are developed, evaluated, and manufactured.
Strategic Plan for Regulatory Science
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.
Regulatory Science-Related Agency Activities
- Improving Pediatric and Child Care
- Developing Products for Global Infectious Disease and Bioterrorism
- Enhancing Safety and Health Through Informatics
- Protecting the Food Supply
- Meeting the Challenges for Regulating Tobacco
- Modernizing Toxicology to Advance Public Health
Resources For You
- April 22, 2019: Don't miss the 2019 Winners of the America's Got Regulatory Science Talent Presenting at FDA!
- Office of Regulatory Science and Innovation
- Advancing Regulatory Science for Public Health (Archived)
- FDA's Predictive Toxicology Roadmap
- Meet the Faces behind FDA Science
- Check out the latest CERSI Workshops!
- FDA Center/Office Regulatory Science Research Priority Areas for CERSI Program
- Science Board to the Food and Drug Administration
- Healthy Innovation, Safer Families: FDA's 2018 Strategic Policy Roadmap