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U.S. Department of Health and Human Services

About FDA

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Office of Regulatory Science and Innovation


Provides strategic leadership, coordination, infrastructure and support for excellence and innovation in FDA science that will advance the agency's ability to protect and promote the health of the public. 

Major Functions:

  • Supporting high-quality, collaborative scientific activities to address important public health and regulatory issues concerning FDA regulated products, including their evaluation, quality, safety and effectiveness
  • Supporting core scientific capacity and infrastructure
  • Fostering development and use of innovative technologies in product development and evaluation
  • Supporting excellence and the professional development of FDA scientists in all areas (i.e., population/statistical, review, laboratory and manufacturing sciences), including through the Commissioner's Fellowship Program, continuing education and professional activities (including clinical activities, cross center working groups, and other activities), and through scientific exchanges and interactions with universities and others
  • Addressing scientific and public health priorities through support of high quality, peer reviewed scientific research, programs and related activities, both within and outside FDA and collaboratively, and through dissemination of new scientific information, methods and approaches
  • Supporting scientific outreach, training, and collaboration in research and development activities that advance FDA's mission and that engage other agencies, global regulatory partners, academia, innovators, and consumers
  • Seeking input from both FDA programs, stakeholders and outside advisors, including the FDA Science Board, to help define, review and meet FDA scientific needs and priorities to support our public health mission