Since its enactment in 1938, FDA has seen an enormous increase in the magnitude and complexity of its regulatory responsibilities. New areas of science, evolving technologies, and globalization have profoundly altered the Agency's regulatory landscape.
Today FDA's regulatory activities range from developing new models to assess the safety of gene therapy to building a new prevention-based food safety system for a globalized economy and creating a national electronic system that will track the safety of FDA-regulated medical products once they reach the market.
However, the success of these efforts depends on an FDA that is positioned to incorporate emerging technologies into the tools and approaches it uses to monitor and evaluate the safety and efficacy of new and licensed products.
FDA's Eight Science Priority Areas for Advancing Regulatory Science
To help meet the challenges of modern product development and globalization, the Agency has developed and is implementing its Strategic Plan for Advancing Regulatory Science, the science of creating new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of its regulated products.
FDA's plan highlights eight priority areas (listed below) in which our increased involvement is crucial to driving innovation, improving regulatory decision-making, and getting safe and effective products to people who need them when they need them:
- Transform Toxicology to Enhance Product Safety
- Stimulate Innovation in Clinical Trials and Personalized Medicine
- Support New Ways to Improve Product Manufacturing and Quality
- Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
- Harness Data through Information Sciences to Improve Health Outcomes
- Implement a New Prevention-Based Food Safety System
- Support Medical Countermeasure Development to Protect National Health and Security
- Strengthen Social and Behavioral Science to Promote Informed Decision-Making About FDA-Regulated Products
FDA is addressing these regulatory science areas through programs within the Agency and in collaboration with our partners in government, academia, and industry to protect and promote the health of our nation and the global community.