Advances in science are leading toward fundamental changes in the way medical treatments and diagnostics are being developed and used. Groundbreaking discoveries in complex chemistry and biosynthesis hold the promise of yielding new drug candidates, and cutting-edge electronics, nanotechnology and materials science have revolutionized medical devices.
Emerging fields such as gene therapy, cell therapy, tissue engineering, optogenetics, high intensity focused ultrasound, and information technology are also yielding innovative approaches to improve our health. These new and complex approaches to health, foods, and medical products present growing challenges to FDA’s readiness to evaluate new products. Regulatory science must be one step ahead to equip FDA with the necessary tools and methods to reliably assess the safety and efficacy of products derived from these new scientific developments, in order to bring the rewards of discovery safely forward to benefit patients.
FDA is working to develop the expertise and infrastructure to evaluate new and emerging technologies through active research intramurally and through external collaborations to address following needs:
- Stimulate development of innovative medical products while developing new assessment tools and methodologies
- Develop assessment tools for new therapies
- Ensure safe and effective medical innovation, and
- Coordinate regulatory science for emerging technology product areas.