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U.S. Department of Health and Human Services

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Office of Critical Path Programs


Four images: Woman looking through microscope, Gloved hands holding test tube, Pills coming down a manufacturing shoot., Doctor holding a baby



The Critical Path Initiative (CPI) is FDA's national strategy for transforming the way FDA-regulated products are developed, evaluated, and manufactured. The Division of Science Innovation and Critical Path supports CPI efforts across the agency.

Major Functions

  • Serves as the nexus for cutting-edge, cross-center scientific and medical initiatives as well as policy development related to CPI and CPI-related activities in the Office of the Commissioner
  • Plans, executes, and monitors CPI projects, including with other agencies, academia, and industry
  • Supports the development and use of innovative technologies in product development and evaluation
  • Addresses scientific and public health priorities by supporting peer reviewed scientific research, programs, and related activities, within and external to FDA
  • Seeks feedback from FDA programs, stakeholders, and external advisors, including the FDA Science Board, to help define, review and meet FDA scientific needs and priorities to support our public health mission

About Critical Path


Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD