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.
2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science
This report—updated for 2022—outlines the Focus Areas of Regulatory Science (FARS) that FDA has identified as needing continued investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Each FARS aligns with one of four strategic initiatives.
Regulatory Science-Related Agency Activities
- Science & Research (Biologics)
- 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
- America's Got Regulatory Science Talent Competition
- Office of Regulatory Science and Innovation
- 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
- Advancing Regulatory Science for Public Health (Archived)
- Strategic Plan for Regulatory Science
- Science Board to the Food and Drug Administration
- Healthy Innovation, Safer Families: FDA's 2018 Strategic Policy Roadmap