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  1. Advancing Regulatory Science

Priority Area 4: Ensure FDA Readiness to Evaluate Emerging Technologies

Images representing Nanotechnology, New Diagnostics, and DNA Analysis


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.

FDA is working to develop the expertise and infrastructure to evaluate new and emerging technologies through active research intramurally as well as through collaborations and funding extramural research to:

  • 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.

Extramural Research Funded through the BAA:

  1. Patient-Centered Benefit/Risk Assessments: Developing a Useful Methodology for Integrating Patient-Centered Perspectives into Regulatory Decisions